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Volume 29 No. 2<br />

<strong>Summer</strong> <strong>2019</strong><br />

<strong>Gastroenterology</strong> <strong>Today</strong><br />

Improving Quality in Endoscopy<br />

Guess the three diagnoses in these Gastric Images to win an iPad<br />

See page 3<br />

What approach has 18 Week Support<br />

taken with regards to building an<br />

expert insourcing team?<br />

Matthew’s Perspective:<br />

Dr Matthew Banks is the Clinical Director for 18 Week Support <strong>Gastroenterology</strong>. He believes it starts with recruiting the<br />

best clinicians. ‘At 18 Week Support we set the bar very high. We only recruit clinicians whose JAG performance data is well<br />

above the national standards. In addition, we monitor each clinician’s KPIs while they work with 18 WS. While the JAG data<br />

is an excellent quality indicator, we now want to go a step beyond that and monitor the Non-Technical skills (NTS) of each<br />

clinician as well. We now know that NTS plays an important role in safe and effective team performance. Therefore, in our<br />

quest to develop excellent teams who deliver a world-class service, we must focus on NTS’.<br />

Tammy and Lisa’s Perspective:<br />

Tammy Kingstree is Lead Nurse for Endoscopy.<br />

‘It is extremely important that there are good working relationships within the team. This starts with strong leadership from<br />

our senior nurse coordinators who are trained to manage the patient pathway, manage a team of staff they may not know<br />

and to deal effectively with any issues which may arise on the day’.<br />

Lisa Phillips is Lead Nurse for Endoscopy.<br />

‘The team objectives are clear. Excellent patient experience and good patient outcomes. Because the objectives are clear,<br />

team cohesion and focus are exceptionally good. It therefore shouldn’t matter that we are in an unfamiliar endoscopy unit,<br />

the service should be seamless. If it isn’t, we do not stop until we get it right.<br />

18 Week Support <strong>Gastroenterology</strong>:<br />

Building Expert Teams<br />

If you have an excellent NHS record and want to help clear NHS waiting list backlogs, reduce RTT waiting times and provide<br />

high-quality patient care, get in touch by calling on 020 3892 6162 or email Gastro.Recruitment@18weeksupport.com


One 5-ASA<br />

stands out<br />

from the crowd;<br />

so your UC patients<br />

don’t have to.<br />

Unique among 5-ASAs, only PENTASA has ethyl cellulose coated microgranules that release<br />

mesalazine independent of pH. 1-10 Alongside this, PENTASA:<br />

• Is effective in 2 weeks 11,12 and remission is maintained for 12 months 13,14<br />

• Is effective throughout the entire colon including left-sided disease 1,13-15<br />

• Offers a broad range of formulations allowing high dose * ,<br />

once-daily dosing: 4 g – active, 2 g – remission 1,16-21<br />

Giving your mild to moderate UC patients the confidence to enjoy life.<br />

*1 g tablets, 1 g, 2 g and 4 g sachets<br />

Prescribing Information: Pentasa ® all formulations. Please consult the full<br />

Summary of Product Characteristics before prescribing. Name of Product(s):<br />

Pentasa ® Sachet prolonged release granules 1g, 2g and 4g; Pentasa ® Slow Release<br />

Tablets 500mg and 1g; Pentasa® Mesalazine Enema 1g; Pentasa ® Suppositories 1g.<br />

Composition: Sachets: contain 1g, 2g or 4g mesalazine. Tablets: contain 500mg<br />

or 1g mesalazine. Enema: contains 1g mesalazine in 100ml of aqueous suspension.<br />

Suppositories: contain 1g mesalazine. Indication: Sachets and Tablets: Mild to<br />

moderate ulcerative colitis. Enema: ulcerative colitis affecting the distal colon and<br />

rectum. Suppositories: ulcerative proctitis. Dosage: Sachets and Tablets: Adults:<br />

Active disease: up to 4g once daily or in 2–4 divided doses. Maintenance treatment:<br />

2g once daily. Sachets and 500mg tablet: Children over 6 years old: Active disease:<br />

individual dosing, starting with 30-50 mg/kg/day in divided doses (total dose should<br />

not exceed 4g/day). Maintenance treatment: individual dosing, starting with 15-30<br />

mg/kg/day in divided doses (total dose should not exceed 2g/day). Enema: Adults:<br />

one enema at bedtime. Suppositories: Adults: 1 suppository daily.Contraindications:<br />

patients with known hypersensitivity to salicylates or any of the excipients and patients<br />

with severe liver and/or renal impairment. Special Warnings and Precautions:<br />

Blood tests (differential blood count: liver function parameters such as ALT or AST;<br />

serum creatinine) and urinary status should be determined prior to and during<br />

treatment, at the discretion of the treating physician. Caution is recommended in<br />

patients with impaired hepatic function. PENTASA should not be used in patients<br />

with impaired renal function. Mesalazine- induced renal toxicity should be considered,<br />

if renal function deteriorates during treatment. Patients with pulmonary disease, in<br />

particular asthma, should be very carefully monitored during a course of treatment<br />

with PENTASA. Patients with a history of adverse drug reactions to preparations<br />

containing sulphasalazine (risk of allergy to salicylates), should be kept under close<br />

medical surveillance on commencement of a course of treatment with PENTASA.<br />

Should PENTASA cause acute intolerance reactions such as abdominal cramps,<br />

acute abdominal pain, fever, severe headache and rash, the treatment should be<br />

discontinued immediately. Mesalazine-induced cardiac hypersensitivity reactions<br />

(myo- and pericarditis) have been reported rarely. Treatment should be discontinued<br />

on suspicion or evidence of these reactions. In patients who are concomitantly treated<br />

with azathioprine, or 6-mercaptopurine, or thioguanine, a possible increase in the<br />

myelosuppressive effects of azathioprine, or 6-mercaptopurine, or thioguanine<br />

should be taken into account. There may be a decrease in the anticoagulant effect<br />

of warfarin. Do not use during pregnancy and lactation except when the potential<br />

benefits outweigh the possible risk. Sachets: Caution is recommended in patients with<br />

active peptic ulcer disease. The concurrent use of other known nephrotoxic agents,<br />

such as NSAID’s and azathioprine, may increase the risk of other renal reactions.<br />

Enema and Suppositories: If a patient develops dehydration while on treatment with<br />

mesalazine, normal electrolyte levels and fluid balance should be restored as soon as<br />

possible. Side effects: For the full list of side effects please consult the Summaries of<br />

Product Characteristics. PENTASA 1g 2g 4g sachets: Common: Headache, Diarrhoea,<br />

Abdominal pain, Nausea, Vomiting, Flatulence. Rare: Acute pancreatitis. Very rare:<br />

Benign intracranial hypertension, Pericardial effusion, Quincke’s oedema, Dermatitis<br />

allergic, Hypersensitivity reaction including anaphylactic reaction, Drug Reaction<br />

with Eosinophilia and Systemic Symptoms (DRESS). Pentasa all formulations: Rare:<br />

Dizziness, Myocarditis, Pericarditis, Photosensitivity. Very rare: Altered blood counts,<br />

Hypersensitivity reaction such as Allergic exanthema, Drug fever, Lupus erythematosus<br />

syndrome, Pancolitis, Peripheral neuropathy, Allergic and Fibrotic lung reactions,<br />

Changes in liver function parameters, Hepatitis and Cholestatic hepatitis, (Reversible)<br />

Alopecia, Renal function impairment interstitial, nephritis (incl. acute and chronic) Renal<br />

insufficiency, reversible Oligospermia. PENTASA 1g 2g 4g sachets, 1g enema and 1g<br />

suppository: Common: Rash. Rare: Increased amylase. Very rare: Cirrhosis, Hepatic<br />

failure, Erythema multiforme Stevens Johnson Syndrome (SJS), Nephrotic syndrome,<br />

Urine discolouration. PENTASA 500mg and 1g tablets, 1g enema and 1g suppository:<br />

Rare: Abdominal pain, Diarrhoea, Flatulence, Nausea, Vomiting, Headache. Very Rare:<br />

Acute Pancreatitis. Nature and Contents of Container: Sachets: Cartons contain 50 x<br />

1g sachets, 60 x 2g sachets or 30 x 4g sachets. Tablets: Cartons contain 100 x 500mg and<br />

60 x 1g tablets in blister strips. Enema: Cartons contain 7 x 100ml enemas. Suppositories:<br />

Cartons contain 28 x 1g suppositories in blister strips.Marketing Authorisation<br />

Number: Sachet 1g: 03194/0075. Sachet 2g: 03194/0102. Sachet 4g: PL 03194/0117.<br />

Tablets 500mg: 03194/0044. Tablets 1g: 3194/0108. Enema: 03194/0027. Suppositories:<br />

03194/0045. Marketing Authorisation Holder: Ferring Pharmaceuticals Ltd., Drayton<br />

Hall, Church Road, West Drayton, UB7 7PS, United Kingdom. Legal Category: POM.<br />

Basic NHS Price: £30.74 for 50 x 1g sachets. £73.78 for 60 x 2g sachets. £73.78 for<br />

30 x 4g sachets. £30.74 for 100 x 500mg Tablets. £36.89 for 60 x 1g Tablets. £17.73<br />

for 7 x enemas. £40.01 for 28 x 1g suppositories. Date of Preparation of Prescribing<br />

Information: January <strong>2019</strong>. Pentasa ® is a registered trademark. PA/035/<strong>2019</strong>/UK.<br />

Adverse events should be reported. Reporting forms<br />

and information can be found at www.mhra.gov.uk/<br />

yellowcard. Adverse events should also be reported<br />

to Ferring Pharmaceuticals Ltd. Tel: 0800 111 4126.<br />

Email: medical@ferring.com<br />

References: 1. Pentasa Slow Release Tablets 500 mg. SmPC.<br />

2. Sulfasalazine 250 mg/5 ml Oral Suspension. SmPC. 3. Octasa 400<br />

mg MR Tablets. SmPC. 4. Asacol 400 mg MR Tablets. SmPC. 5. Mezavant<br />

XL 1200 mg, Gastro-resistant, Prolonged Release Tablets. SmPC.<br />

6. Salofalk 500 mg Gastro-resistant Prolonged Release Granules. SmPC.<br />

7. Colazide 750 mg Capsules. SmPC. 8. Olsalazine Sodium 250 mg Capsules.<br />

SmPC. 9. Salazopyrin En-Tabs. SmPC. 10. Salazopyrin Tablets SmPC.<br />

11. Probert C.S.J, et al. J Crohn’s Colitis. 2014;8:200–7. 12. Marteau P, et al. Gut.<br />

2005;54(7):960–5. 13. Dignass AU, et al. Clin Gastroenterol Hepatol. 2009;7(7):762–<br />

9. 14. Bokemeyer B, et al. J Crohn’s Colitis. 2012;6:476-82. 15. Flourie B,<br />

et al. Aliment Pharmacol Ther. 2013;37(8):767–75. 16. Pentasa Slow Release Tablets 1 g.<br />

SmPC. 17. Pentasa Sachet 1 g. SmPC. 18. Pentasa Sachet 2 g. SmPC. 19. Pentasa<br />

Sachet 4 g. SmPC. 20. Pentasa Enema 1 g. SmPC. 21. Pentasa Suppositories 1 g. SmPC.<br />

Date of preparation: May <strong>2019</strong>. Job code: PA/323/<strong>2019</strong>/UKa<br />

MAKING A<br />

Positive UC action. Positive UC outcomes.<br />

DIFFERENCE<br />

Positive UC a


CONTENTSMatthew’s Perspective:<br />

5 EDITORS COMMENT<br />

6 CASE REPORT Primary Aorto-enteric Fistula<br />

14 FEATURE Showing the true value of probiotics<br />

17 NEWS<br />

26 COMPANY NEWS<br />

What approach has 18 Week Support<br />

CONTENTS<br />

taken with regards to building an<br />

expert insourcing team?<br />

<strong>Gastroenterology</strong> <strong>Today</strong><br />

Dr Matthew Banks is the Clinical Director for 18 Week Support <strong>Gastroenterology</strong>. He believes it starts with recruiting the<br />

best clinicians. ‘At 18 Week Support we set the bar very high. We only recruit clinicians whose JAG performance data is well<br />

above the national standards. In addition, we monitor each clinician’s KPIs while they work with 18 WS. While the JAG data<br />

is an excellent quality indicator, we now want to go a step beyond that and monitor the Non-Technical skills (NTS) of each<br />

clinician as well. We now know that NTS plays an important role in safe and This effective issue team performance. edited by: Therefore, in our<br />

quest to develop excellent teams who deliver a world-class service, we must focus on NTS’.<br />

Dr Ben Shandro<br />

Tammy and Lisa’s Perspective:<br />

c/o Media Publishing Company<br />

Tammy Kingstree is Lead Nurse for Endoscopy.<br />

Media House<br />

‘It is extremely important that there are good working relationships within the team. This starts with strong leadership from<br />

48 High Street<br />

our senior nurse coordinators who are trained to manage the patient pathway, manage a team of staff they may not know<br />

SWANLEY, Kent BR8 8BQ<br />

and to deal effectively with any issues which may arise on the day’.<br />

Lisa Phillips is Lead Nurse for Endoscopy.<br />

ADVERTISING & CIRCULATION:<br />

‘The team objectives are clear. Excellent patient experience and good patient outcomes. Because the objectives are clear,<br />

Media Publishing Company<br />

team cohesion and focus are exceptionally good. It therefore shouldn’t matter that we are in an unfamiliar endoscopy unit,<br />

the service should be seamless. If it isn’t, we do not stop until we get it right. Media House, 48 High Street<br />

SWANLEY, Kent, BR8 8BQ<br />

If you have an excellent NHS record and want to help clear NHS waiting list Tel: backlogs, 01322 reduce 660434 RTT waiting Fax: times 01322 and provide 666539<br />

high-quality patient care, get in touch by calling on 020 3892 6162 or email Gastro.Recruitment@18weeksupport.com<br />

E: info@mediapublishingcompany.com<br />

www.MediaPublishingCompany.com<br />

COVER STORY<br />

What are the three diagnoses evident in these<br />

gastric images?<br />

Submit your answers to jawuku@18weeksupport.com to enter our prize<br />

draw to win an iPad! The Competition will end on the 21st of June.<br />

The winner will be announced on the 18 Week Support website.<br />

What approach has 18 Week Support taken with regards to building an<br />

expert insourcing team?<br />

Matthew’s Perspective:<br />

Dr Matthew Banks is the Clinical Director for 18 Week Support <strong>Gastroenterology</strong>.<br />

He believes it starts with recruiting the best clinicians. ‘At 18 Week Support we<br />

set the bar very high. We only recruit clinicians whose JAG performance data<br />

is well above the national standards. In addition, we monitor each clinician’s<br />

KPIs while they work with 18 WS. While the JAG data is an excellent quality<br />

indicator, we now want to go a step beyond that and monitor the Non-Technical<br />

skills (NTS) of each clinician as well. We now know that NTS plays an important<br />

role in safe and effective team performance. Therefore, in our quest to develop<br />

excellent teams who deliver a world-class service, we must focus on NTS’.<br />

Tammy and Lisa’s Perspective:<br />

Tammy Kingstree is Lead Nurse for Endoscopy.<br />

‘It is extremely important that there are good working relationships within the team.<br />

This starts with strong leadership from our senior nurse coordinators who are trained<br />

to manage the patient pathway, manage a team of staff they may not know and to<br />

deal effectively with any issues which may arise on the day’.<br />

Lisa Phillips is Lead Nurse for Endoscopy.<br />

‘The team objectives are clear. Excellent patient experience and good patient outcomes.<br />

Because the objectives are clear, team cohesion and focus are exceptionally good.<br />

It therefore shouldn’t matter that we are in an unfamiliar endoscopy unit, the service<br />

should be seamless. If it isn’t, we do not stop until we get it right.<br />

For more information please contact: Ian Yuill, Director of Business Development<br />

& Recruitment on 0203 869 8792 or visit www.18weeksupport.com<br />

PUBLISHING DATES:<br />

February, June and October.<br />

COPYRIGHT:<br />

Media Publishing Company<br />

Media House<br />

48 High Street<br />

SWANLEY, Kent, BR8 8BQ<br />

PUBLISHERS STATEMENT:<br />

The views and opinions expressed in<br />

this issue are not necessarily those of<br />

the Publisher, the Editors or Media<br />

Publishing Company.<br />

Next Issue Autumn <strong>2019</strong><br />

Subscription Information – <strong>Summer</strong> <strong>2019</strong><br />

<strong>Gastroenterology</strong> <strong>Today</strong> is a tri-annual<br />

publication currently sent free of charge to<br />

all senior qualified Gastroenterologists in<br />

the United Kingdom. It is also available<br />

by subscription to other interested individuals<br />

and institutions.<br />

UK:<br />

Other medical staff - £18.00 inc. postage<br />

Non-medical Individuals - £24.00 inc. postage<br />

Institutions<br />

Libraries<br />

Commercial Organisations - £48.00 inc. postage<br />

Rest of the World:<br />

Individuals - £48.00 inc. postage<br />

Institutions<br />

Libraries<br />

Commercial Organisations - £72.00 inc. postage<br />

We are also able to process your<br />

subscriptions via most major credit<br />

cards. Please ask for details.<br />

Cheques should be made<br />

payable to MEDIA PUBLISHING.<br />

Designed in the UK by me&you creative<br />

GASTROENTEROLOGY TODAY - SUMMER <strong>2019</strong><br />

3


Getting on with<br />

their lives<br />

By getting on with<br />

their steroid<br />

For autoimmune hepatitis<br />

The only budesonide with three indications<br />

For induction of remission of mild to moderate active<br />

ileo-caecal Crohn’s disease<br />

For induction of remission of active collagenous colitis<br />

Budesonide, the Dr Falk way<br />

Efficacy localised at the site of the diseases 1-4<br />

Limiting the risk of systemic side effects 2-4<br />

Prescribing Information (Please refer to full SPC before prescribing)<br />

Presentation: Budenofalk ® gastro-resistant granules, each sachet<br />

contains 9mg budesonide, Budenofalk ® gastro-resistant capsules, each<br />

containing 3mg budesonide. Indications: Induction of remission of<br />

mild to moderate active Crohn’s disease affecting the ileum and/or the<br />

ascending colon. Induction of remission of active collagenous colitis.<br />

Autoimmune hepatitis (capsules only). Dosage: Adults: For Crohn’s<br />

disease and collagenous colitis: one sachet or three capsules daily with<br />

liquid half an hour before food, without chewing or crushing, or one<br />

capsule three times daily. Limit treatment to 8 weeks, then withdraw<br />

gradually. For autoimmune hepatitis: one capsule three times daily.<br />

Possibly combine with azathioprine. Maintenance of remission: one<br />

capsule twice daily. Revert to 3 capsules daily if transaminases ALAT and/<br />

or ASAT elevate again. Treat until remission is achieved or 24 months.<br />

Children: Not recommended; safety and efficacy not established. Contraindications:<br />

hypersensitivity to any constituent. Hepatic cirrhosis.<br />

Warnings/Precautions: Change from other steroids may result in<br />

symptoms due to reduced systemic steroids. Use with caution in patients<br />

with tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic<br />

ulcer, glaucoma, cataracts or family history of glaucoma or diabetes or any<br />

condition in which glucocorticosteroids may have undesirable effects.<br />

Not appropriate for upper GI Crohn’s or extraintestinal symptoms.<br />

Long term, high dose use may result in glucocorticosteroid systemic<br />

effects. Infection: suppression of the inflammatory response and<br />

immune function increases susceptibility to infections and their severity.<br />

Clinical presentation of infections may be atypical and presentation of<br />

serious infections may be masked. Chickenpox and herpes zoster are<br />

of particular concern. Passive immunisation needed within 10 days in<br />

exposed non-immune patients taking systemic glucocorticosteroids.<br />

Urgent specialist care required on confirmed chickenpox. Give normal<br />

immunoglobulin immediately after measles exposure. Do not give<br />

live vaccines to those with chronic glucocorticosteroid use. Antibody<br />

response to other vaccines may be diminished. With severe liver<br />

function disorders: increased systemic bioavailability. Central serous<br />

chorioretinopathy or other causes may result in blurred vision/visual<br />

disturbances. Consider referral to ophthalmologist. Suppression of<br />

the HPA axis and reduced stress response: supplementary systemic<br />

glucocorticoid treatment may be needed. Avoid concomitant treatment<br />

with CYP3A4 inhibitors. Do not use in patients with galactose or fructose<br />

intolerance, glucose – galactose malabsorption, sucrase – isomaltase<br />

insufficiency or Lapp lactase deficiency or congenital lactase deficiency.<br />

In autoimmune hepatitis evaluate transaminase levels every 2 weeks<br />

for the first month and then every 3 months. Interactions: Co-treatment<br />

with CYP3A inhibitors including cobicistat containing products may<br />

increase side effects and should be avoided where possible. Beware<br />

concomitant administration of cardiac glycosides and saluretics.<br />

CYP3A4 inhibitors: avoid concomitant administration. CYP3A4<br />

inducers: may reduce systemic and local exposure, necessitating dose<br />

adjustment of budesonide. CYP3A4 substrates: may compete with<br />

budesonide increasing plasma concentrations depending on relative<br />

affinities. Small, non-significant effect of cimetidine on budesonide<br />

kinetic effects. Oestrogens/oral contraceptives may elevate plasma<br />

concentrations and enhance corticosteroid effects. Steroid-binding<br />

compounds and antacids may reduce budesonide efficacy; administer<br />

at least 2 hours apart. Because adrenal function may be supressed,<br />

an ACTH stimulation test for diagnosing pituitary insufficiency might<br />

show false results (low values). Use in pregnancy and lactation: Avoid<br />

use in pregnancy unless essential. Do not breastfeed during Budenofalk<br />

treatment. Undesirable effects: Cushing’s syndrome, growth retardation<br />

in children, glaucoma, cataracts, blurred vision, dyspepsia, abdominal<br />

pain, constipation, gastric or duodenal ulcers, pancreatitis, increase in<br />

risk of infections, muscle and joint pain and weakness and twitching,<br />

osteoporosis, osteonecrosis, headache, pseudotumor cerebri (including<br />

papilloedema) in adolescents, depression, irritability and euphoria,<br />

www.drfalk.co.uk<br />

Dr Falk Pharma UK Ltd, Unit K, Bourne End Business Park, Cores End Rd, Bourne End, SL8 5AS. Registered in England No: 2307698<br />

psychomotor hyperactivity, anxiety, aggression, allergic exanthema,<br />

petechiae, ecchymosis, contact dermatitis, delayed wound healing,<br />

increased risk of thrombosis, vasculitis (after withdrawal from longterm<br />

treatment), fatigue, malaise. Side effects characteristic of systemic<br />

glucocorticosteroid therapy may occur. Exacerbation or reappearance of<br />

extraintestinal manifestations when switching from systemically acting<br />

glucocorticosteroids may occur. Frequency is likely to be lower than<br />

with equivalent dosage of prednisolone. Legal category: POM. Costs:<br />

UK NHS: 60 sachets £135.00; 100 capsules £75.05. Ireland (PtW):<br />

60 sachets: €149.49; 100 capsules: €78.96. Licence holder: Dr Falk<br />

Pharma GmbH, Leinenweberstr.5, D-79108 Freiburg, Germany. Licence<br />

numbers: (granules) PL08637/0020 (UK) PA573/2/3 (IE) (capsules)<br />

PL08637/0002 (UK) PA573/2/1 (IE). Prepared: February <strong>2019</strong>.<br />

Further information available on request.<br />

Adverse events should be reported. Reporting forms and information<br />

can be found at www.mhra.gov.uk/yellowcard or search for MHRA<br />

Yellow Card in the Google Play, Apple App Store (UK residents) or<br />

at email: medsafety@hpra.ie or at http://www.hpra.ie/homepage/<br />

about-us/report-an-issue/human-adverse-reaction-form (residents<br />

in Ireland). Adverse events should also be reported to Dr Falk<br />

Pharma UK Ltd.<br />

References:<br />

1. Bar-Meir S et al. Gastroenterol 1998; 115(4): 835-40. 2. De Cassan C<br />

et al. Dig Des 2012; 30(4): 368-75. 3. Czaja AJ. Dig Dis Sci 2012; 57(8):<br />

1996-2010. 4. Miehlke S et al. Gastroenterol 2002; 123(4): 978-84.<br />

DrF19/003<br />

Date of preparation: March <strong>2019</strong>


EDITORS COMMENT<br />

EDITORS COMMENT<br />

Seek and ye shall find<br />

“As with<br />

all rare<br />

diagnoses,<br />

the critical<br />

first step<br />

is to<br />

consider<br />

it.”<br />

The case-report by Arakkal et al. included in this edition of <strong>Gastroenterology</strong> <strong>Today</strong> presents<br />

a rare cause of a common presentation, and highlights the importance of including these in<br />

the differential diagnosis.<br />

Arakkal et al. describe a case of acute upper GI bleeding secondary to primary aortoenteric<br />

fistula. The diagnosis of primary aorto-enteric fistula requires cross-sectional<br />

imaging, which does not form part of the GI bleeding pathway in most international<br />

guidelines. These patients could exsanguinate whilst awaiting their colonoscopy or video<br />

capsule endoscopy, the two investigations usually advocated after negative upper GI<br />

endoscopy. If this rare diagnosis had not been considered, and the CT scan requested,<br />

then the diagnosis could not have been made.<br />

Early identification of patients with aorto-enteric fistula is paramount, as it is common<br />

to present with a smaller herald bleed prior to catastrophic GI haemorrhage. Presenting<br />

symptoms are non-specific. Routine physical examination is only moderately sensitive for<br />

detecting abdominal aortic aneurysm (AAA), even when the physical examination is directed<br />

specifically to the detection of AAA.<br />

In contrast, ultrasound and CT imaging are highly sensitive. Could there be a role for<br />

focussed ultrasound scanning in the emergency department for at-risk patients who present<br />

with GI bleeding, such as those aged over 60 years?<br />

As with all rare diagnoses, the critical first step is to consider it.<br />

Dr Ben Shandro<br />

Research Fellow in <strong>Gastroenterology</strong><br />

St George’s Hospital<br />

GASTROENTEROLOGY TODAY - SUMMER <strong>2019</strong><br />

5


CASE REPORT<br />

PRIMARY AORTO-ENTERIC FISTULA -<br />

A CASE REPORT<br />

1. Dr Mohammed Shaheer Pandara Arakkal, Senior Clinical Fellow , <strong>Gastroenterology</strong>, Morriston hospital, Swansea Wales, UK<br />

2. Dr.Umakant Dave, Consultant Gastroenterologist, , Morriston Hospital, Swansea Wales, UK<br />

3. Victoria Trainer, Consultant Radiologist, Singleton Hospital, Swansea Wales, UK<br />

Abstract<br />

Aorto-enteric fistula is a life threatening condition and is defined as<br />

an abnormal communication between the abdominal aorta and<br />

gastrointestinal tract. It is most often secondary to either erosion of an<br />

aortic prosthetic graft or other vascular procedure on the aorta, known as<br />

secondary aorto-enteric fistulae (SAEF). Primary aorto-enteric fistula (PAEF)<br />

occurs as a result of compression of an abdominal aortic aneurysm (AAA)<br />

against the surrounding gastrointestinal structures causing spontaneous<br />

communication between them. We describe a case of PAEF in an 85 year<br />

old woman who was known to have AAA who presented with acute upper<br />

gastrointestinal haemorrhage to the emergency department. This report<br />

highlights the importance of high index of suspicion in diagnosing aortoenteric<br />

fistula, especially if the patient is known to have AAA.<br />

Introduction<br />

Primary aorto-enteric fistula (PAEF) is an abnormal communication<br />

between abdominal aorta and gastrointestinal (GI) tract in the absence of<br />

any vascular intervention on aorta. Secondary aorto-enteric fistula occurs<br />

as a complication of endovascular procedures with prosthesis or stent<br />

graft or a surgical procedure usually for an AAA repair. Primary aortoenteric<br />

fistula (PAEF) is a rare but serious differential diagnosis that must<br />

be considered in any patients who presents with upper gastro intestinal<br />

(GI) haemorrhage, especially if the patient is known to have an abdominal<br />

aortic aneurysm (AAA). Although aorto-enteric fistula (AEF) has several<br />

aetiologies, the most common cause of PAEF is AAA. As PAEF is quite<br />

a challenging diagnosis for the treating physician, early detection and<br />

treatment is vital for the patient survival. If left untreated mortality is 100%.<br />

This is a case report of a patient with known AAA who was found to have<br />

Aorto- duodenal fistula while investigating for Upper GI haemorrhage.<br />

Case Report<br />

An 85 year old lady presented to the Emergency department (ED) in<br />

October 2018 with two episodes of haematemesis and one episode<br />

melaena. She had a further episode of melaena in the ED. She had a<br />

background history of coronary artery bypass graft (CABG) in 1993, chronic<br />

obstructive pulmonary disease (COPD), osteoporosis, varicose eczema<br />

and high cholesterol. She was an ex-heavy smoker with a 50 pack-year<br />

smoking history and consumed alcohol occasionally. No previous history<br />

of upper GI haemorrhage. Her regular medications were Co-Codamol,<br />

Alendronic acid, Lansoprazole, Oxybutynin, Gabapentin, GTN spray,<br />

Isosorbide mononitrate, Paroxetine, Diltiazem, Aspirin and Atorvastatin.<br />

GASTROENTEROLOGY TODAY - SUMMER <strong>2019</strong><br />

6<br />

Image [1] CT image on previous admission showing A-Abdominal<br />

Aortic Aneurysm (AAA) belly. B-Duodenum clinging around the aortic<br />

aneurysm, but no gas with in the aneurysm<br />

Image 1<br />

Three months prior to the last admission she presented to the ED after<br />

a fall and sustained a fracture dislocation of the left shoulder. A chest<br />

X-ray then showed a small density in the left upper zone measuring<br />

approximately 12mm. She underwent surgery for her fracture and was<br />

discharged from the hospital. An outpatient CT thorax and abdomen<br />

performed two months later to evaluate the lung mass incidentally<br />

revealed a 6.4 cm abdominal aortic aneurysm, which extended down<br />

to the bifurcation. The descending thoracic aorta was also aneurysmal<br />

[Image 1]. The mass in the lung was reported as possible fibrosis. She<br />

was referred to vascular surgeons for further management of AAA.<br />

A decision was made by the vascular surgery team not to intervene<br />

because of the morphology of aneurysm, as well as patient’s age,<br />

comorbidities and frailty.<br />

Blood results during the last admission with GI haemorrhage revealed<br />

an Hb of 94 g/L (112 g/L when discharged home from previous<br />

admission), white cell count of 34.1 x10^9/L (neutrophil count 30.8<br />

x10^9/L), platelet count of 352 x10^9/L, MCV of 90 fL. U&Es revealed<br />

Na-143 mmol/L, K-4.5 mmol/L, Urea 8.6 mmol/L, creatinine 95 umol/L,<br />

CRP-20 mg/L, normal LFTs and normal clotting parameters.


CASE REPORT<br />

You’ve probably<br />

never seen an oral iron<br />

like FERACCRU ® before<br />

For the treatment of adults with iron defi ciency<br />

anaemia (IDA) 1<br />

PRESCRIBING INFORMATION: Feraccru 30mg hard<br />

capsules (ferric maltol)<br />

Please refer to the full Summary of Product Characteristics<br />

(SmPC) before prescribing.<br />

Presentation: Red hard capsules. Each capsule contains<br />

30 mg iron (as ferric maltol). Indication: Feraccru is<br />

indicated in adults for the treatment of iron defi ciency.<br />

Dosage and Administration: Adults: Feraccru should be<br />

taken orally. The whole capsule should be taken on an<br />

empty stomach (with half a glass of water). The<br />

recommended dose is one capsule twice daily, in the<br />

morning and evening. The absorption of iron is reduced<br />

when Feraccru is taken with food. Treatment duration will<br />

depend on the severity of iron defi ciency but generally at<br />

least 12 weeks treatment is required. The treatment should<br />

be continued as long as necessary to replenish the body<br />

iron stores according to blood tests. Elderly: No dose<br />

adjustment is necessary. Children: The safety and effi cacy<br />

of Feraccru in children (17 years and under) has not yet<br />

been established. No data are available. Patients with<br />

hepatic or renal impairment: No clinical data is available<br />

in this patient population. Contraindications:<br />

Hypersensitivity to the active substance or to any of the<br />

excipients; Haemochromatosis and other iron overload<br />

syndromes; Patients receiving repeated blood<br />

transfusions. Warnings and precautions: Feraccru should<br />

not be used in patients with infl ammatory bowel disease<br />

(IBD) fl are or in IBD patients with haemoglobin (Hb) levels<br />


CASE REPORT<br />

Examination revealed HR-95 b/m, BP 130/70 mm Hg, oxygen saturation<br />

96% on 2 Litres of oxygen and normal temperature. Abdominal<br />

examination revealed a large pulsatile abdominal mass. PR examination<br />

revealed melaena on glove. She scored 10 points on the Glasgow-<br />

Blatchford Bleeding Score.<br />

After resuscitation with IV fluids and blood products the patient was<br />

transferred to the ward. She had 3 further large episodes of melaena<br />

on the same day and was taken to the endoscopy unit for upper GI<br />

endoscopy which did not reveal blood in the upper GI tract, but did<br />

show a deep ulcer in the second part of duodenum (D2) [Image 2&3].<br />

Post- endoscopy Rockall Score was 6. The consultant who performed<br />

the endoscopy was concerned about the morphology of the ulcer<br />

and recommended a CT scan and urgent surgical review to rule out<br />

a primary aorto-enteric fistula [PAEF]. In view of high suspicion of a<br />

PAEF, the endoscopist elected not to perform endotherapy used for<br />

bleeding duodenal ulcer. A 3 phase CT abdomen and pelvis revealed<br />

an increase in size of the infrarenal abdominal aortic aneurysm [AAA]<br />

which measured 8 cm [Image 4] (6.4cm previously [Image 1]). New<br />

gas locules within the inferior aspect of aneurysm sac were highly<br />

suggestive of aorto-enteric fistulation. The aortic sac was inseparable<br />

from the proximal duodenum and tracking gas locules were suggestive<br />

of a communication between aneurysm sac and second part of<br />

duodenum [Image 4]. An urgent vascular review was requested and<br />

vascular surgeons decided not to surgically intervene as the patient<br />

was very frail and unlikely to survive a repair. This was discussed with<br />

the patient and her daughter and decision for palliation was made. The<br />

patient had another massive haematemesis and melaena early in the<br />

morning of the next day and died after a few hours.<br />

Discussion<br />

Formation of fistula between aorta and intestinal tract was first described<br />

by an English Surgeon Sir Ashley Cooper in 1829 [1]. But the first case<br />

report of PAEF was published by Salmon in 1843. Since then only about<br />

400 of PAEF cases have been reported up until now [2&3]. PAEF is a<br />

potentially fatal and a rare complication of untreated aortic aneurysm,<br />

which warrants a high index of clinical suspicion when presented with<br />

upper GI haemorrhage. The fistula most commonly erodes into an<br />

area of intestine (most commonly the third part of duodenum) which<br />

has close contact with the pulsating aortic segment [4, 5&6]<br />

The classical triad of symptoms with abdominal pain, pulsatile<br />

abdominal mass and gastrointestinal haemorrhage are only found<br />

in 6-12% of patients [7&8]. The most common presentation is upper<br />

GI haemorrhage. Often the initial GI bleeding is small (herald bleed),<br />

but one third of the patients presents with massive recurrent bleeding<br />

within 6 hours [9]. Many patients with aorto-enteric fistula (AEF) die<br />

before an accurate diagnosis is made due to its variable clinical<br />

manifestations and insufficient awareness of this rare entity among<br />

non-specialty clinicians. Although literature review suggests the most<br />

common aetiology for PAEF are atherosclerotic and traumatic AAA,<br />

other causes include radiation, cancer, metastasis, gallstone erosion,<br />

ulcers, diverticulitis appendicitis, aortitis, infections like TB, pancreatic<br />

pseudo cyst penetration and foreign body ingestion[10&3].<br />

Unusual features of this case include the fistulous connection between<br />

the AAA and second part of duodenum and the presence of a deep<br />

ulcer on endoscopy. Even though no literature is available to confirm,<br />

it is possible that standard endotherapy for bleeding duodenal ulcer<br />

(adrenaline injection, heater probe, gold probe coagulation and<br />

endoclip placement) may lead to massive haemorrhage in patients<br />

with aorto-enteric fistula. In our patient, possibility of PAEF was<br />

considered very high and endotherapy was not attempted.<br />

Though less frequent, there are reports in literature that described<br />

abnormal communication between aorta and other pat of GI tract such<br />

as the oesophagus, jejunum, ileum and colon, but most of these were<br />

secondary to endovascular or other surgical procedures on aorta<br />

causing secondary fistulation [11].<br />

GASTROENTEROLOGY TODAY - SUMMER <strong>2019</strong><br />

Image [2] A-Endoscopic view of deep ulcer in D2<br />

Image [3] A-Endoscopic view of deep ulcer in D2<br />

Image 2<br />

8<br />

Image 3


Life feels good when they’re under control 1-8<br />

CASE REPORT<br />

CROHN’S DISEASE<br />

Indicated for the induction of<br />

remission in patients with mild to<br />

moderate active Crohn’s disease<br />

affecting the ileum and/or the<br />

ascending colon 9<br />

ULCERATIVE COLITIS<br />

Indicated for ulcerative<br />

colitis involving rectal and<br />

recto-sigmoid disease 10<br />

MICROSCOPIC<br />

COLITIS<br />

Indicated for the induction<br />

and maintenance of remission<br />

in patients with microscopic<br />

colitis 9<br />

Entocort ® CR is the ONLY<br />

LICENSED TREATMENT<br />

for the induction and<br />

maintenance of remission<br />

in microscopic colitis 9<br />

ENTOCORT CR 3mg Capsules (budesonide) - Prescribing Information<br />

Please consult the Summary of Product Characteristics (SmPC) for full<br />

prescribing Information<br />

Presentation: Hard gelatin capsules for oral administration with an opaque,<br />

light grey body and an opaque, pink cap marked CIR 3mg in black radial print.<br />

Contains 3mg budesonide. Indications: Induction of remission in patients with<br />

mild to moderate Crohn’s disease affecting the ileum and/or the ascending<br />

colon. Induction of remission in patients with active microscopic colitis.<br />

Maintenance of remission in patients with microscopic colitis. Dosage and<br />

administration: Active Crohn’s disease (Adults): 9mg once daily in the morning<br />

for up to eight weeks. Full effect achieved in 2-4 weeks. When treatment is to<br />

be discontinued, dose should normally be reduced in final 2-4 weeks. Active<br />

microscopic colitis (Adults): 9mg once daily in the morning. Maintenance of<br />

microscopic colitis (Adults): 6mg once daily in the morning, or the lowest<br />

effective dose. Paediatric population: Not recommended. Older people: No<br />

special dose adjustment recommended. Swallow whole with water. Do not<br />

chew. Contraindications: Hypersensitivity to the active substance or any of the<br />

excipients. Warnings and Precautions: Side effects typical of corticosteroids<br />

may occur. Visual disturbances may occur. If a patient presents with symptoms<br />

such as blurred vision or other visual disturbances they should be considered<br />

for referral to an ophthalmologist for evaluation of the possible causes.<br />

Systemic effects may include glaucoma and when prescribed at high doses for<br />

prolonged periods, Cushing’s syndrome, adrenal suppression, growth<br />

retardation, decreased bone mineral density and cataract. Caution in patients<br />

with infection, hypertension, diabetes mellitus, osteoporosis, peptic ulcer,<br />

glaucoma or cataracts or with a family history of diabetes or glaucoma.<br />

Particular care in patients with existing or previous history of severe affective<br />

disorders in them or their first degree relatives. Caution when transferring from<br />

glucocorticoid of high systemic effect to Entocort CR. Chicken pox and measles<br />

may have a more serious course in patients on oral steroids. They may also<br />

suppress the HPA axis and reduce the stress response. Reduced liver function<br />

may increase systemic exposure. When treatment is discontinued, reduce<br />

dose over last 2-4 weeks. Concomitant use of CYP3A inhibitors, such as<br />

ketoconazole and cobicistat-containing products, is expected to increase the<br />

risk of systemic side effects and should be avoided unless the benefits<br />

outweigh the risks. Excessive grapefruit juice may increase systemic exposure<br />

and should be avoided. Patients with fructose intolerance, glucose-galactose<br />

malabsorption or sucrose-isomaltase insufficiency should not take Entocort CR.<br />

Monitor height of children who use prolonged glucocorticoid therapy for risk of<br />

growth suppression. Interactions: Concomitant colestyramine may reduce<br />

Entocort CR uptake. Concomitant oestrogen and contraceptive steroids may<br />

increase effects. CYP3A4 inhibitors may increase systemic exposure. CYP3A4<br />

inducers may reduce systemic exposure. May cause low values in ACTH<br />

stimulation test. Fertility, pregnancy and lactation: Only to be used during<br />

pregnancy when the potential benefits to the mother outweigh the risks for the<br />

foetus. May be used during breast feeding. Adverse reactions: Common:<br />

Cushingoid features, hypokalaemia, behavioural changes such as nervousness,<br />

insomnia, mood swings and depression, palpitations, dyspepsia, skin reactions<br />

(urticaria, exanthema), muscle cramps, menstrual disorders. Uncommon:<br />

anxiety, tremor, psychomotor hyperactivity. Rare: aggression, glaucoma,<br />

cataract, blurred vision, ecchymosis. Very rare: Anaphylactic reaction, growth<br />

retardation. Prescribers should consult the summary of product characteristics<br />

in relation to other adverse reactions. Marketing Authorisation Numbers,<br />

Package Quantities and basic NHS price: PL 36633/0006. Packs of 100<br />

capsules: £84.15. Legal category: POM. Marketing Authorisation Holder:<br />

Tillotts Pharma UK Ltd, The Stables, Wellingore Hall, Wellingore, Lincoln, LN5<br />

0HX. Date of preparation of PI: November 2018<br />

ENTOCORT (budesonide) ENEMA - Prescribing Information<br />

Please consult the Summary of Product Characteristics (SmPC) for full<br />

prescribing Information<br />

Presentation: 0.02 mg/ml budesonide (2 mg budesonide/100 ml) solution for<br />

rectal suspension. Each Entocort Enema consists of 2 components: a 2.3 mg<br />

faintly yellow, circular biconvex tablet with the engraving BA1 on one side and<br />

2.3 on the other side; a 115 ml clear colourless solution. Indications: Ulcerative<br />

colitis involving rectal and recto-sigmoid disease. Dosage and administration:<br />

Route of administration: rectal. Adults: One Entocort Enema nightly for 4<br />

weeks. Full effect is usually achieved within 2–4 weeks. If the patient is not in<br />

remission after 4 weeks, treatment may be prolonged to 8 weeks. Paediatric<br />

population: Not recommended. Older people: Dosage as for adults. No dosage<br />

reduction in patients with reduced liver function. Instruct the patient to read the<br />

instructions for use. Reconstitute the enema immediately before use. Ensure<br />

the tablet is completely dissolved. Administer in the evening before bed.<br />

Contraindications: Hypersensitivity to the active substance or the excipients.<br />

Warnings and Precautions: Side effects typical of corticosteroids may occur,<br />

including glaucoma. Visual disturbances may occur. If a patient presents with<br />

symptoms such as blurred vision or other visual disturbances they should be<br />

considered for referral to an ophthalmologist for evaluation. When patients are<br />

transferred from steroids of higher systemic effect they may have adrenocortical<br />

suppression; monitoring may be considered and the dose of systemic steroid<br />

should be reduced cautiously. Replacement of high systemic effect steroid<br />

treatment with Entocort enema sometimes unmasks allergies which were<br />

previously controlled by the systemic drug. Reduced liver function affects the<br />

elimination of glucocorticosteroids, causing lower elimination rate and higher<br />

systemic exposure, with possible systemic side effects. Care when considering<br />

systemic corticosteroids in patients with existing or previous history of severe<br />

affective disorders in themselves or first degree relatives e.g. depressive or<br />

manic-depressive illness and previous steroid psychosis. Systemic effects<br />

of steroids may occur, particularly at high doses and for prolonged periods,<br />

including Cushing’s syndrome, adrenal suppression, growth retardation,<br />

decreased bone mineral density, cataract, glaucoma and very rarely a wide<br />

range of psychiatric/behavioural effects. Contains lactose and methyl-,<br />

propyl-parahydroxybenzoate. Caution in patients with hypersensitivity to<br />

these. Some patients may feel unwell in a non-specific way during withdrawal.<br />

When Entocort Enema is used chronically in excessive doses, systemic<br />

glucocorticosteroid effects may appear. However, the dosage form and the<br />

route of administration make any prolonged overdosage unlikely. Interactions:<br />

Raised plasma concentrations and enhanced effects of corticosteroids have<br />

been reported in women also treated with oestrogens and contraceptive<br />

steroids. Inhibitors of CYP3A4 can increase systemic exposure to budesonide<br />

several times and the combination should be avoided. If this is not possible, the<br />

period between treatments should as long as possible, and a reduction of the<br />

budesonide dose could also be considered. Other potent inhibitors of CYP3A4<br />

are also likely to markedly increase plasma levels of budesonide. Concomitant<br />

treatment with CYP3A4 inducers may reduce budesonide exposure and<br />

require a dose increase. Because adrenal function may be suppressed, an<br />

ACTH stimulation test for diagnosing pituitary insufficiency might show low<br />

values. Fertility, pregnancy and lactation: Only to be used during pregnancy<br />

when the potential benefits to the mother outweigh the risks for the foetus. May<br />

be used during breast feeding. Adverse reactions: Common: depression,<br />

gastrointestinal disturbances (flatulence, nausea, diarrhoea), skin reactions<br />

(urticaria, exanthema). Uncommon: agitation, insomnia, anxiety, psychomotor<br />

hyperactivity, duodenal or gastric ulcer. Rare: signs or symptoms of systemic<br />

glucocorticosteroid effects, aggression, glaucoma, cataract including<br />

subcapsular cataract, blurred vision, pancreatitis, ecchymosis, osteonecrosis.<br />

Very rare: anaphylactic reaction. Prescribers should consult the summary<br />

of product characteristics in relation to other adverse reactions. Marketing<br />

Authorisation Numbers, Package Quantities and basic NHS price: PL<br />

36633/0007. Packs of 7 enemas: £33.66. Legal category: POM. Marketing<br />

Authorisation Holder: Tillotts Pharma UK Ltd, The Stables, Wellingore Hall,<br />

Wellingore, Lincoln, LN5 0HX. Date of preparation of PI: March 2018<br />

Adverse events should be reported. Reporting forms and<br />

information can be found at https://yellowcard.mhra.gov.uk.<br />

Adverse events should also be reported to Tillotts Pharma<br />

UK Ltd. Tel: 01522 813500.<br />

References: 1. Greenberg GR et al. N Engl J Med 1994;331:836-841.<br />

2. Rezaie A et al. Cochrane Database Syst Rev 2015;6:CD000296.<br />

3. Madisch A et al. Int J Colorectal Dis 2005;20(4):312-316. 4. Hofer KN. Ann<br />

Pharmacother 2003;37:1457-1464. 5. Miehlke S et al. <strong>Gastroenterology</strong><br />

2008;135:1510-1516. 6. Gross V et al. Aliment Pharmacol Ther 2006;23:303-<br />

312. 7. Hartmann F et al. Aliment Pharmacol Ther 2010;32(3):368-376.<br />

8. Danielsson A et al. Scand J Gastroenterol 1992;27(1):9-12. 9. Entocort ® CR<br />

3mg Capsules – Summary of Product Characteristics. November 2018.<br />

10. Entocort ® Enema – Summary of Product Characteristics. March 2018.<br />

Date of<br />

preparation:<br />

December 2018.<br />

PU-00225.<br />

GASTROENTEROLOGY TODAY - SUMMER <strong>2019</strong><br />

9


CASE REPORT<br />

GASTROENTEROLOGY TODAY - SUMMER <strong>2019</strong><br />

10<br />

The diagnosis of aorto-enteric fistula typically is delayed, as long as 1<br />

month in 50% of patients in one series, with the diagnosis being made<br />

within 10 days of hospitalization in only 15% of cases [12]. Urgent upper<br />

GI endoscopy is important for exclusion of common causes of massive<br />

upper GI bleeding; but the diagnostic sensitivity for aorto-enteric fistula<br />

has been reported to be as low as 25% [12]. Gastrointestinal bleeding<br />

with endoscopically unclear findings in a patient with aortic aneurysm or<br />

history of aortic repair should points towards an aorto-enteric fistula [13].<br />

The most valuable tool for diagnosing AEF is a CT scan with contrast,<br />

which may reveal gas within the aneurysm, destruction of the fat plane<br />

between the aneurysm and duodenum, proximity and connection<br />

between aorta and intestine and leaking of the contrast into the GI lumen;<br />

all highly suggestive of AEF [14]. MRI is less useful because of its limited<br />

availability in the emergency setting, longer acquisition time, need for<br />

local technical expertise, and potential difficulties differentiating peri-graft<br />

gas from aortic wall calcification. All other investigation modalities like<br />

white blood cell scan are of limited value in diagnosing AEF. Percutaneous<br />

angiography has a sensitivity of 94 percent and a specificity of 85 percent<br />

for detecting aorto-enteric fistula (AEF); but is rarely considered as<br />

most patients are critically ill by the time of a decision is made to do it<br />

[15&16]. ]. A high index of suspicion is paramount, supplemented by the<br />

judicious use of upper endoscopy and CT, and the attending physician<br />

must be willing to recommend exploratory laparotomy if clinical suspicion<br />

is sufficiently high. As immediate and correct diagnosis is difficult, the<br />

mortality is very high and an untreated AEF has 100% mortality. Mortality<br />

of invasively treated patients is approximately 50 %. [17].<br />

Conclusion<br />

Although AEF is an extremely rare cause of upper GI haemorrhage, it<br />

must always be considered and ruled out in GI haemorrhages. A herald<br />

Image [4] Coronal reconstruction on this portal venous CT study<br />

demonstrates A-Abdominal Aortic Aneurysm (AAA) belly which has<br />

increased in size compared to previous CT image B-New gas locule<br />

within the inferior aspect of aneurysm sac C-Inseparable aortic sac<br />

from the proximal duodenum and tracking gas locules suggestive of a<br />

Image communication 4 between aneurysm sac and second part of duodenum<br />

bleed followed by a an endoscopy is usually the first step in diagnosis.<br />

This case highlights the importance of high index of suspicions in<br />

diagnosing AEF, especially if the patient is known to have AAA. PAEF<br />

is rare if the patient is not known to have AAA; but an accurate clinical<br />

evaluation to rule out an abdominal bruit or pulsatile mass should be<br />

done to rule out AEF. AEF is potentially fatal. An early diagnosis with<br />

prompt surgical management has huge prognostic benefits.<br />

References<br />

1. Cooper A. Lectures on the Principles and Practice of Surgery, London 1829<br />

2. Abdu Hassan Alzobydi and Shaista Salman Guraya. Primary aortoduodenal fistula: A case<br />

reportWorld J Gastroenterol. 2013 Jan 21; 19(3): 415–417.Published online 2013 Jan<br />

21. doi: 10.3748/wjg.v19.i3.415<br />

3. Daniele Bissacco, Luca Freni, Luca Attisani, Iacopo Barbetta, Raffaello Dallatana, and<br />

Piergiorgio Settembrini. Unusual clinical presentation of primaryaortoduodenal fistula.<br />

Gastroenterol Rep (oxf). 2015 may; 3(2): 170–174. Published online 2014 Jun 30. doi:<br />

10.1093/gastro/gou040<br />

4. Jarboui S, Jarraya H, Mahjoub W, Baccar M, Kacem C, Abdesselem MM, Zaouche A.<br />

Primary aorto-enteric fistula in a 52-year-old man. Tunis Med. 2008 Sep; 86(9):830-2.<br />

5. Debonnaire P, Van Rillaer O, Arts J, Ramboer K, Tubbax H, Van Hootegem P. Primary aorto<br />

enteric fistula: Report of 18 Belgian cases and literature review. Acta Gastroenterol Belg.<br />

2008 Apr-Jun; 71(2):250-8.<br />

6. O’Mara C, Imbembo AL. Paraprosthetic-enteric fistula. Surgery. 1977 May; 81(5):556-66.<br />

7. Calligaro KD, Bergen WS, Savarese RP, Westcott CJ, Azurin DJ, Delaurentis DA. Primary<br />

aortoduodenal fistula due to septic aortitis. J Cardiovasc Surg (Torino). 1992 Mar-Apr;<br />

33(2):192-8.<br />

8. Voorhoeve R,Moll FL, De letter JA, Bast TJ Wester JP, Slee PH. Primary aortoenteric<br />

fistula: Report of eight new cases and review of the literature. Ann Vasc Surg. 1996 Jan;<br />

10(1):40-8.<br />

9. Fernández de Sevilla E, Echeverri JA, Boqué M, Valverde S, Ortega N, Gené A, Rodríguez<br />

N, Balibrea JM, Armengol M. Life-threating upper gastrointestinal bleeding due to<br />

a primary aorto-jejunal fistula. Int J Surg Case Rep. 2015; 8C:25-8. doi: 10.1016/j.<br />

ijscr.2015.01.010. Epub 2015 Jan 9.<br />

10. Sharma K, Kibria R, Ali S, Rao P. Primary aortoenteric fistula caused by an infected<br />

abdominal aortic aneurysm with Mycobacterium avium complex in an HIV patient. Acta<br />

Gastroenterol Belg. 2010 Apr-Jun; 73(2):280-2.<br />

11. Sin-Jae Kang, Dong-LK, Kim, Se-Ho Huh, Byung-Boong Lee, Duk-Kyung Kim, and<br />

Young-Soo Do. Coexisting aortocolic and aortovesical fistulae in an abdominal aortic<br />

aneurysm: Report of a case. Surgery today. June 2003, Volume 33, Issue 6, pp 441–443.<br />

12. Pipinos II, Carr, J.A., Haithcock, B.E., Anagnostopoulos, P.V., Dossa, C.D., and Reddy, D.J.<br />

Secondary aorto-enteric fistula. Ann Vasc Surg. 2000; 14: 688–696).<br />

13. Franke S, Debus ES, Voit R. Aorto-intestinal fistula as a possible cause of endoscopically<br />

undetermined gastrointestinal hemorrhage. [Article in German]. Chirurg. 1995 Feb;<br />

66(2):112-9<br />

14. Saers SJ, Scheltinga MR. Diagnostic image (154). A man with haematemesis and gas in<br />

the aorta. Primary aorto-enteric fistula. [Article in Dutch]. Ned tijdschr geneeskd. 2003<br />

Aug 30; 147(35):1686<br />

15. Yeong KY. Angiographic demonstration of primary aorto-enteric fistula--A case report.<br />

Ann Acad Med Singapore. 1995 May; 24(3):467-9.<br />

16. Huges FM1, Kavanagh D Barry M, Owen A, Macerlaine DP, Malone de, Aortoenteric<br />

Fistula: a diagnostic dialemma. Abdom imaging.2007 May-Jun; 32(3):398-402.epub<br />

2006 Aug 25<br />

17. Behrendt CA, Wipper S, Debus SE, von Kodolitsch Y, Püschel K, Kammal M, Kammal<br />

A. Primary aorto-enteric fistula as a rare cause of massive gastrointestinal haemorrhage.<br />

Vasa. 2017 Oct; 46(6):425-430. doi: 10.1024/0301-1526/a000646. Epub 2017 Jun 30.<br />

Consent for Publication<br />

Written consent obtained<br />

Address for correspondence<br />

Dr Mohammed Shaheer Pandara Arakkal, Senior Clinical fellow in<br />

<strong>Gastroenterology</strong>, House G, Morriston Hospital, Swansea SA6 6NL


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Its multi-strain bacteria arrives<br />

in a live and active state,<br />

ready to act in the gut<br />

Its water-based nature survives<br />

stomach acid, allowing the<br />

bacteria to reach the gut intact<br />

Bacteria are clinically proven<br />

to rapidly colonise in the<br />

gut, contributing to gut<br />

microbiome balance<br />

To find out more about Symprove TM contact<br />

01252 413 600 or support@symprove.com<br />

www.symprove.com/bioscience<br />

GASTROENTEROLOGY TODAY - SUMMER <strong>2019</strong><br />

References:<br />

1. Freuda-Agyeman, M et al. (2014). Comparative survival of commercial probiotic formulations: tests in biorelevant gastric fluids and real-time measurements using<br />

microcalorimetry. Beneficial Microbes. 6(1). 141-151<br />

2. Data on file. Results from a Symprove TM Customer Survey<br />

3. Wang, B et al. (2017). The human microbiota in health and disease. Engineering 3(1). 71-82<br />

4. Sisson G, Ayis S, Sherwood RA and Bjarnason I. (2014). Randomised clinical trial: A liquid multi-strain probiotic vs. placebo in the irritable bowel syndrome<br />

– a 12 week double-blind study. Aliment Pharmacol Ther 40. 51-62<br />

11


Dr. Daniel Vinteler<br />

CEO and Founder of Plasmabiotics, invented the PlasmaTYPHOON<br />

and PlasmaBAG; a device designed to minimize the risk of bacterial<br />

contamination in endoscopy. Daniel Vinteler has been in close contact<br />

with patients from the very beginning. This has provided him with a<br />

comprehensive understanding of the hygiene risks in endoscopy and<br />

this revolutionary new way to reduce them.<br />

‘Drying is a possible pitfall for hygiene<br />

in endoscopy’<br />

The diagnostic and therapeutic utility of Endoscopic Retrograde Cholangio-Pancreatography (ERCP) has been well demonstrated<br />

for a variety of disorders, such as the management and treatment of biliopancreatic diseases. Due to their complex design,<br />

duodenoscopes have been long recognized to require thorough processes and precise execution to properly disinfect.<br />

As the importance of ERCP procedures and their impact on patients’ lives remains unwavering. We speak to Dr. Daniel Vinteler<br />

(PlasmaBiotics) and Ulrike Beilenhoff (ESGENA) about their ideas concerning the challenges and solutions for the future of<br />

endoscopy and PlasmaBiotics latest technology, the PlasmaTYPHOON.<br />

How important is it to raise awareness<br />

about the risk of infection, during endoscopy<br />

procedures in a cross functional<br />

way?<br />

Ulrike Beilenhoff: Hygiene is an important<br />

concern as it relates to patient’s safety.<br />

Hospitals have the task to ensure a safe<br />

environment in order to prevent any adverse<br />

events and complications. The patient is in a<br />

vulnerable situation, they may have existing<br />

health problems, they are undergoing an<br />

endoscopy procedure, and when you expose<br />

the patient to additional germs, you create<br />

an additional risk. Since the early 2000s<br />

we are experiencing problems with multidrug<br />

resistant bacteria. If a patient is ill<br />

and subsequently exposed to this bacteria,<br />

hospitals have limited options to treat the<br />

patient. The aim is to avoid any additional risk<br />

and therefore hygiene is really a core focus in<br />

this commitment. Thus, establishing hygiene<br />

as a commitment to the patient’s safety.<br />

What are the hygiene issues inherent to<br />

endoscope handling and storage?<br />

Daniel Vinteler: Every step of endoscope<br />

reprocessing is crucial to ensure a hygienic<br />

procedure: the pre-cleaning, cleaningdisinfection,<br />

drying and storage. If one of<br />

these steps is not performed correctly,<br />

hygiene is not guaranteed. In practice, the<br />

drying of the endoscope is often underestimated<br />

and therefore a possible pitfall for<br />

hygiene and reprocessing steps. If the scope<br />

is not dried properly, all the steps before are<br />

undercut.<br />

Why is it so crucial to dry an endoscope<br />

after the device has been disinfected?<br />

Ulrike Beilenhoff: Publications showed that<br />

several outbreaks have been caused by<br />

insuffi cient dyring. If you do not clean the<br />

endoscope properly then you leave residual<br />

debris. If you do not dry the endoscope<br />

it creates a perfect environment to breed<br />

germs. Nurses are aware of both of these<br />

steps. A perfectly dried endoscope stops<br />

bacterial proliferation.<br />

What are the key challenges and<br />

constraints in endoscope drying and<br />

storage? Why are these steps sometimes<br />

not perfectly carried out?<br />

Ulrike Beilenhoff: Time constraints in hospitals<br />

present challenges to effective drying and<br />

storage. Surveys showed that nurses and<br />

reprocessing staff work under time pressure.<br />

Even though they are aware of the importance<br />

of thorough cleaning and drying, it can be<br />

challenging. Suffi cient time is the prerequisite<br />

for correct reprocessing of endoscopes and<br />

this also includes suffi cient time for drying<br />

before storage.<br />

It is the responsibility of hospitals as service<br />

providers to ensure a proper training for all<br />

staff involved in endoscope reprocessing.


advertorial<br />

Nurses are not the only individuals working<br />

in scope reprocessing. If staff are not trained<br />

to understand the endoscope channels in<br />

detail, they may struggle to effectively dry the<br />

endoscope.<br />

How does the PlasmaTYPHOON device<br />

completely dry an endoscope?<br />

Daniel Vinteler: The PlasmaTYPHOON offers<br />

a new way to dry and store the scope<br />

with plasma, thereby reducing the risk of<br />

contamination. The drying process with the<br />

PlasmaTYPHOON is managed by a patented<br />

curve of pressure. The unit uses a laminar<br />

fl ow to eliminate the water and a turbulent<br />

heated fl ow to dry the walls.<br />

At PENTAX Medical we are committed<br />

to addressing the hygiene challenges in<br />

endoscopy by offering solutions that minimize<br />

the risk of infections, improve clinical<br />

outcomes, enhance provider experience,<br />

and increase healthcare productivity. We<br />

are actively listening to our customers<br />

and stakeholders, so we understand the<br />

complexity of the procedures and the risk of<br />

infection.<br />

How does the system improve on<br />

existing solutions? What advantages<br />

can staff expect while using the<br />

PlasmaTYPHOON?<br />

Daniel Vinteler: The PlasmaTYPHOON is the<br />

fi rst solution to guarantee a dry endoscope<br />

in up to 5 minutes 1 (the drying time depends<br />

on the endoscope type), and storage up to<br />

31 days 2,3 in a fully controlled environment.<br />

The advantages for staff are numerous<br />

and include saving time and space, cost<br />

reductions, mobility of the scopes while they<br />

are stored in the PlasmaBAG, and of course<br />

an improved level of hygiene.<br />

What advantage do you foresee in a<br />

system such as the PlasmaTYPHOON<br />

and BAG, which dries the scope perfectly<br />

in an automatized way and stores the<br />

scope in a protected environment?<br />

Ulrike Beilenhoff: Hospitals need an easy and<br />

fast system to dry endoscopes. Often medical<br />

professionals cannot visibly see that the<br />

endoscope is wet, as the exterior appears dry,<br />

thus presenting a hygiene challenge.<br />

Daniel Vinteler: The PlasmaTYPHOON offers<br />

a solution to these challenges, by perfectly<br />

drying the endoscope and doing so in an<br />

easy and fast manner. The PlasmaTYPHOON<br />

is the most advantageous option for<br />

endoscope reprocessing as it completes the<br />

task quickly and easily, without compromising<br />

effectiveness.<br />

1. Evaluation of the efficacy of a drying unit for internal channels of endoscopes according to NF S98-030- Test Report by Biotech-Germande February 2015.<br />

2. Evaluation of the ability of a storage system (Plasmabiotics) to maintain the microbiological quality of heat sensitive endoscope. Report by Biotech-Germande April 2017.<br />

3. The maximum storage time may be subject to local regulations on endoscope storage. The country regulation can restrict the maximum storage time to 7 days. Please refer to the relevant regulations or recommendation of your country.<br />

Ulrike Beilenhoff,<br />

Scientifi c Secretary and former President of<br />

the European Society of <strong>Gastroenterology</strong> and<br />

Endoscopy Nurses and Associates (ESGENA).<br />

Ulrike has important insights concerning<br />

the hygiene challenge in endoscopy;<br />

specialized in endoscopy nursing, with 16<br />

years of experience as head nurse in German<br />

Endoscopy Departments.


FEATURE<br />

SHOWING THE TRUE VALUE OF<br />

PROBIOTICS – UNDERSTANDING<br />

THE SCIENCE AND HISTORY IS KEY<br />

Written by Mike Butler, CEO, Symprove<br />

Therapeutic use of probiotics isn’t new. The use of<br />

fermented foods to improve intestinal health has<br />

been recorded back thousands of years, a long time<br />

before there was an ounce of understanding of the gut<br />

microbiome and the importance of its managment. 1<br />

The Russian scientist Eli Metchnikoff (generally believed to be the<br />

‘father of probiotics’) first hypothesised that lactic acid bacteria<br />

provided either a type of protection from, or reversal of, intestinal<br />

auto-intoxication. He won the Nobel Prize in medicine in 1908 by<br />

demonstrating harmful microbes can be replaced by beneficial<br />

microbes to treat intestinal illnesses. His regimen became sour<br />

milk in the hope of populating his digestive tract with Bulgarian<br />

bacillus (Lactobacillus bulgaricus) – the first use of ‘probiotics’<br />

as a dietary supplement. Mehcnikoff laid the foundations for<br />

faecal transplantation, predicted the existence of bacterial<br />

translocation from the intestinal lumen into the bloodstream and<br />

lymphatic system and theories linking chronic inflammation with<br />

atherosclerosis. 2<br />

As our knowledge of the gut microbiome has grown, so has our<br />

scepticism of probiotics. Some of this scepticism is fair, some<br />

not so, as we bucket a group of probiotics which come in various<br />

different shapes and sizes and treat them as equal. This is just<br />

not the case as there are various formulations, bacterial strains,<br />

mode of delivery and impact on microbiota to consider. 3 So what<br />

do we need to do to change perceptions and show the value of<br />

probiotics?<br />

Firstly, we need to be brave like Mehcnikoff and explore the<br />

Health Diagnostics for Digestive Health Management<br />

Meet the experts at BSG<br />

on stand no. 42<br />

SEC Glasgow, 17 th -20 th June<br />

Faecal Immunochemical<br />

Testing (FIT)<br />

for Bowel Cancer Screening or<br />

Symptomatic Assessment<br />

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Name<br />

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GASTROENTEROLOGY TODAY - SUMMER <strong>2019</strong><br />

Calprotectin Testing<br />

Point of Care and Remote<br />

Patient Management<br />

Solutions<br />

Therapeutic Drug<br />

Monitoring<br />

New Quantum Blue ®<br />

Rapid Test for anti-TNFα<br />

Therapeutic Drug Monitoring<br />

Tel: 023 8048 3000 | Web: www.alphalabs.co.uk<br />

M / F<br />

14<br />

DDH+BSG-<strong>2019</strong>_FINAL_13May19.indd 1 13/05/<strong>2019</strong> 16:30:55


FEATURE<br />

possibilities of human health beyond our existing beliefs. Our gut<br />

microbiota contains tens of trillions of micro-organisms, including<br />

at least 1,000 different species of known bacteria with more than<br />

3 million genes (150 times more than human genes). To put it in<br />

perspective, the Human Genome Project took 15 years to complete<br />

so we inevitably have far more to understand about the makeup<br />

of the gut microbiome. However, already we are seeing positive<br />

results for some probiotics in improving people’s health. It will take<br />

time to know the exact potential of probiotics work and also our<br />

understanding of the gut microbiome, its full role and where it can<br />

be adapted to improve lives, but we are working with safe food<br />

supplements which allow us to be braver with their application.<br />

LUTATHERA ® ▼ LUTETIUM<br />

( 177 Lu) OXODOTREOTIDE<br />

Secondly, the balance between science driven and commercial<br />

goals needs to be heavily weighted towards the former. As<br />

probiotics are a safe food supplement, it is easy for some to focus<br />

on market penetration and not mode of action. However, if we are<br />

going to realise the potential of probiotics, an evidence based,<br />

long-term approach needs to be undertaken for all manufacturers<br />

of probiotics.<br />

By following the science, there is a real possibility that we might<br />

find something that is ‘game-changing’. This is already a growing<br />

appetite to push our current perceptions, understanding and<br />

application of probiotics. For example, trials are now looking at the<br />

link between the microbiome Parkinson’s and the gut brain-axis. 4<br />

As we continue to learn about the different ‘good’ bacteria,<br />

the way they arrive in the gut in an alive state, survive hostile<br />

gastric conditions and thrive in the colon, we will get a better<br />

understanding of this complex microsystem that is living inside all<br />

of us.<br />

Ten years from now, I am confident that we will be looking back<br />

at today as the cusp of a revolution, one in which the science-led<br />

probiotics will have an important part to play.<br />

References:<br />

1. Ozen M and Dinleyici EC. The history of probiotics: the untold<br />

story. Benef Microbes. 2015;6(2):159-65.<br />

2. Mackowiak PA. Recycling Metchnikoff: Probiotics, the Intestinal<br />

Microbiome and the Quest for Long Life. Front Public Health.<br />

2013; 1: 52.<br />

3. Gaisford S. et al. Comparative survival of commercial probiotic<br />

formulations: Tests in biorelevant gastric fluids and real-time<br />

measurements using microcalorimetry. Beneficial Microbes<br />

6(1): 1-11 · October 2014<br />

4. Chaudhuri R. Kings Colledge London. Oral Symprove (a<br />

probiotic) for the management of motor and non-motor<br />

symptoms in people with Parkinson’s: a novel randomised,<br />

double-blind, placebo-controlled pilot study.<br />

Lutathera ® ▼ lutetium ( 177 Lu) oxodotreotide is indicated for<br />

the treatment of unresectable or metastatic, progressive,<br />

well differentiated (G1 and G2), somatostatin receptor<br />

positive gastroenteropancreatic neuroendocrine tumours<br />

(GEP NETs) in adults.<br />

www.lutathera.com<br />

Adverse events should be reported. Reporting forms and information can be found at<br />

www.mhra.gov.uk/yellowcard.<br />

Adverse events should also be reported to Advanced Accelerator Applications at:<br />

pharmacovigilance@adacap.com<br />

pv@imagingequipment.co.uk<br />

Tel: 33 (0) 785 61 90 66, Switchboard +334 50 99 30 70, Fax +334 50 99 30 71<br />

Prescribing Information; Lutathera 370 MBq/mL solution for infusion. Lutetium ( 177 Lu)<br />

oxodotreotide Presentation: Solution for infusion. Clear, colourless to slightly yellow solution. One<br />

mL of solution contains 370 MBq of lutetium ( 177 Lu) oxodotreotide at the date and time of calibration.<br />

The total amount of radioactivity per single dose vial is 7,400 MBq at the date and time of infusion.<br />

Uses: Lutathera is indicated for the treatment of unresectable or metastatic, progressive, well<br />

differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine<br />

tumours (GEP NETs) in adults. Administration: Lutathera should be administered only by persons<br />

authorised to handle radiopharmaceuticals in designated clinical settings and after evaluation of<br />

the patient by a qualified physician. Before starting treatment with Lutathera, somatostatin receptor<br />

imaging (scintigraphy or positron emission tomography [PET]) must confirm the overexpression of<br />

these receptors in the tumour tissue with the tumour uptake at least as high as normal liver uptake<br />

(tumour uptake score ≥ 2). Additionally before each administration and during the treatment, tests are<br />

required to re assess the patient’s condition and adapt the therapeutic protocol if necessary (dose,<br />

infusion interval, number of infusions). See SmPC for further details. The recommended treatment<br />

regimen of Lutathera in adults consists of 4 infusions of 7,400 MBq each. The recommended interval<br />

between each administration is 8 weeks which could be extended up to 16 weeks in case of dose<br />

modifying toxicity (DMT). For renal protection purpose, an amino acid solution must be administered<br />

intravenously. See SmPC for further details. Given the fixed volumetric activity of 370 MBq/mL at the<br />

date and time of calibration, the volume of the solution is adjusted between 20.5 mL and 25.0 mL<br />

in order to provide the required amount of radioactivity at the date and time of infusion. Lutathera<br />

must be administered by slow intravenous infusion over approximately 30 minutes, concomitantly<br />

with amino acid solution administered by contralateral intravenous infusion (separate intravenous<br />

catheter and initiated 30 minutes prior to Lutathera). This medicinal product must not be injected<br />

as a bolus. Premedication with antiemetics should be injected 30 minutes before the start of amino<br />

acid solution infusion. The recommended infusion method for administration of Lutathera is the<br />

gravity method. During the administration the recommended precaution measures should be<br />

undertaken. Lutathera should be infused directly from its original container. The vial must not be<br />

opened or the solution transferred to another container. During the administration only disposable<br />

materials should be used. The medicinal product should be infused through an intravenous catheter<br />

placed in the vein exclusively for its infusion. See SmPC for further details of storage, room and<br />

equipment requirements, as well as detailed administration procedure. In some circumstances,<br />

it might be necessary to temporarily discontinue treatment with Lutathera, adapt the dose after<br />

the first administration or discontinue the treatment. General Warnings: Contraindications<br />

include hypersensitivity to the active substance, to any of the excipients, established or suspected<br />

pregnancy or when pregnancy has not been excluded, kidney failure with creatinine clearance<br />

< 30 mL/min. Special precautions should be taken where patients have renal or urinary tract<br />

morphological abnormalities, urinary incontinence, mild to moderate chronic kidney disease with<br />

creatinine clearance ≥ 50 mL/min, haematologic toxicity greater or equal to grade 2 (CTCAE) before<br />

treatment other than lymphopenia, bone metastasis or have had previous chemotherapy. Late-onset<br />

myelodisplastic syndrome (MDS) and acute leukaemia (AL) have been observed after treatment with<br />

Lutathera, factors such as age >70 years, impaired renal function, baseline cytopenias, prior number<br />

of therapies, prior exposure to chemotherapeutic agents (specifically alkylating agents), and prior<br />

radiotherapy are suggested as potential risks and/or predictive factors. Crises due to excessive<br />

release of hormones or bioactive substances may occur and overnight hospitalisation should be<br />

considered for vulnerable patients. Radioprotection rules should be followed including special<br />

care in the event of extravasation and urinary incontinence, see SmPC for full details or radio<br />

protective measures. The product contains up to 3.5 mmol sodium and this should be considered<br />

in patients on a sodium controlled diet. Undesirable effects: Common side effects include bone<br />

marrow toxicity with thrombocytopenia, lymphopenia, anaemia<br />

or pancytopenia. Nephrotoxicity with haematuria, renal failure,<br />

proteinuria. Blood creatinine increased, nausea, vomiting,<br />

fatigue, QT prolonged, hypertension, flushing, hypotension,<br />

dyspnoea, abdominal distension, diarrhoea, abdominal pain,<br />

constipation, dyspepsia, gastritis, hyperbilirubinaemia, alopecia,<br />

musculoskeletal pain, muscle spasms, acute kidney injury,<br />

increased LFTs. Marketing Authorisation Holder: Advanced<br />

Accelerator Applications 20 rue Diesel 01630 Saint Genis Pouilly<br />

France Marketing Authorisation Number EU/1/17/1226/001<br />

Legal Category: POM Price: £17,875 per vial Date of<br />

preparation of PI: October 2017<br />

Date of preparation: May <strong>2019</strong><br />

Job ID Number: AAA.Lu177-UKI-0013<br />

AAA-Lu177-GL-0028<br />

GASTROENTEROLOGY TODAY - SUMMER <strong>2019</strong><br />

15


From Norgine, the company that brought you<br />

MOVIPREP<br />

NEWS<br />

® (Macrogol 3350, sodium sulphate, ascorbic acid, sodium ascorbate and electrolytes)<br />

The first 1 litre PEG bowel preparation 1-3<br />

Improve the efficacy<br />

cut the volume<br />

vs MOVIPREP ®1<br />

PLENVU® PM/AM dosing was<br />

superior to MOVIPREP® in the per<br />

protocol population (successful<br />

overall cleansing 97.3% vs 92.2%,<br />

p=0.014)<br />

Safety profile comparable to<br />

MOVIPREP® 1,4-6<br />

Powder for Oral Solution<br />

PEG 3350, Sodium Ascorbate, Sodium<br />

Sulfate, Ascorbic Acid, Sodium Chloride,<br />

and Potassium Chloride<br />

UK AND IE PRESCRIBING INFORMATION: Plenvu powder for oral solution<br />

(Macrogol 3350 + Sodium ascorbate + Ascorbic acid + Sodium sulfate<br />

anhydrous + Potassium chloride + Sodium chloride)<br />

Please refer to the full Summary of Product Characteristics (SmPC)<br />

before prescribing.<br />

Presentation: Plenvu powder for oral solution is administered in two doses. Dose<br />

one is made up of 1 sachet containing: macrogol 3350 100g, sodium sulfate<br />

anhydrous 9g, sodium chloride 2g, potassium chloride 1g. Dose 2 is made up of<br />

2 sachets (A and B). Sachet A contains: macrogol 3350 40g, sodium chloride 3.2g,<br />

potassium chloride 1.2g. Sachet B contains: sodium ascorbate 48.11g, ascorbic<br />

acid 7.54g.<br />

Indication: For bowel cleansing in adults, prior to any procedure requiring a clean<br />

bowel.<br />

Dosage and administration: For oral use. Adults and elderly: A course of<br />

treatment consists of two separate non-identical 500ml doses of Plenvu. At least<br />

500ml of additional clear fluid must be taken with each dose. Treatment can be<br />

taken according to a two-day or one-day dosing schedule. Two-day dosing schedule:<br />

First dose taken the evening before the procedure. Second dose in the early morning<br />

of the day of the procedure. Morning only dosing schedule: Both doses taken the<br />

morning of the procedure. The two doses should be separated by a minimum of<br />

1 hour. Day before dosing schedule: Both doses taken the evening before the<br />

procedure. The two doses should be separated by a minimum of 1 hour. No solid<br />

food should be taken from the start of the course of treatment until after the clinical<br />

procedure. Consumption of all fluids should be stopped at least 2 hours prior to a<br />

procedure under general anaesthesia or 1 hour prior to a procedure without general<br />

anaesthesia. Children: Not recommended for use in children below 18 years of<br />

age. Patients with renal or hepatic impairment: No special dosage adjustment<br />

is deemed necessary in patients with mild to moderate renal or hepatic impairment.<br />

GASTROENTEROLOGY TODAY - SUMMER <strong>2019</strong><br />

Patients should be advised to allow adequate time after bowel movements have<br />

subsided to travel to the clinical unit.<br />

Contraindications: Hypersensitivity to the active substances or to any of the<br />

excipients, gastrointestinal obstruction or perforation, ileus, disorders of gastric<br />

emptying (gastroparesis, gastric retention), phenylketonuria, glucose-6-phosphate<br />

dehydrogenase deficiency, toxic megacolon.<br />

Warnings and precautions: The fluid content of reconstituted Plenvu does not<br />

replace regular fluid intake. Adequate fluid intake must be maintained. As with<br />

other macrogol containing products, allergic reactions including rash, urticaria,<br />

pruritus, angioedema and anaphylaxis are a possibility. Caution should be used<br />

with administration to frail or debilitated patients, in patients with impaired gag<br />

reflex, with the possibility of regurgitation or aspiration, or with diminished levels<br />

of consciousness, severe renal impairment, cardiac failure (grade III or IV of NYHA),<br />

those at risk of arrhythmia, dehydration or severe acute inflammatory bowel disease.<br />

16<br />

In debilitated fragile patients, patients with poor health, those with clinically significant<br />

renal impairment, arrhythmia and those at risk of electrolyte imbalance, the physician<br />

should consider performing a baseline and post-treatment electrolyte, renal function<br />

test and ECG as appropriate.<br />

Any suspected dehydration should be corrected for before use of Plenvu.<br />

There have been rare reports of serious arrhythmias including atrial fibrillation<br />

associated with the use of ionic osmotic laxatives for bowel preparation, predominantly<br />

in patients with underlying cardiac risk factors and electrolyte disturbance.<br />

If patients develop any symptoms indicating arrhythmia or shifts of fluid/electrolytes<br />

during or after treatment, plasma electrolytes should be measured, ECG monitored<br />

and any abnormality treated appropriately.<br />

If patients experience severe bloating, abdominal distension, or abdominal pain,<br />

administration should be slowed or temporarily discontinued until the symptoms<br />

subside.<br />

The sodium content, 458.5mmol (10.5g), should be taken into consideration for<br />

patients on a controlled sodium diet. The potassium content, 29.4mmol (1.1g), should<br />

be taken into consideration by patients with reduced kidney function or those on a<br />

controlled potassium diet.<br />

Interactions: Medicinal products taken orally within one hour of starting colonic<br />

lavage with Plenvu may be flushed from the gastrointestinal tract unabsorbed. The<br />

therapeutic effect of drugs with a narrow therapeutic index or short half-life may be<br />

particularly affected.<br />

Fertility, pregnancy and lactation: There are no data on the effects of Plenvu on<br />

fertility in humans. There were no effects on fertility in studies in male and female rats.<br />

It is preferable to avoid the use of Plenvu during pregnancy.<br />

It is unknown whether Plenvu active ingredients/metabolites are excreted in human<br />

milk. A risk to the newborns/infants cannot be excluded. A decision must be made<br />

whether to discontinue breast-feeding or to abstain from Plenvu therapy taking into<br />

account the benefit of breast-feeding for the child and the benefit of therapy for<br />

the woman.<br />

Effects on ability to drive and use machines: Plenvu has no influence on the ability<br />

to drive and use machines.<br />

Undesirable effects: Diarrhoea is an expected outcome.<br />

Common: vomiting, nausea, dehydration. Uncommon: abdominal distension,<br />

anorectal discomfort, abdominal pain, drug hypersensitivity, headache, migraine,<br />

somnolence, thirst, fatigue, asthenia, chills, pains, aches, palpitation, sinus<br />

tachycardia, transient increase in blood pressure, hot flush, transient increase in<br />

liver enzymes, hypernatraemia, hypercalcaemia, hypophosphataemia, hypokalaemia,<br />

decreased bicarbonate, anion gap increased/ decreased, hyperosmolar state.<br />

Refer to the SmPC for a full list and frequency of adverse events.<br />

UNITED KINGDOM:<br />

Price and pack sizes: £12.43 (3 sachet)<br />

Legal category: Pharmacy medicine<br />

MA Number: PL 20011/0040<br />

MA Holder: Norgine Pharmaceuticals Limited, Norgine House, Widewater Place,<br />

Moorhall Road, Harefield, Uxbridge, UB9 6NS, UK<br />

IRELAND<br />

Legal category: Product subject to medical prescription which may be renewed<br />

MA Number: PA 1336/005/001<br />

MA Holder: Norgine BV, Hogehilweg 7, 1101CA Amsterdam ZO, The Netherlands<br />

Additional information is available on request or in the SmPC. For further<br />

information contact: Norgine Pharmaceuticals Limited, Norgine House,<br />

Moorhall Road, Harefield, Middlesex, United Kingdom UB9 6NS. Telephone:<br />

+44(0)1895 826606. Email: medinfo@norgine.com<br />

Date of preparation: March <strong>2019</strong><br />

Company reference: UK/PLV/0319/0147<br />

United Kingdom<br />

Adverse events should be reported. Reporting forms and<br />

information can be found at www.mhra.gov.uk/yellowcard.<br />

Adverse events should also be reported<br />

to Norgine Pharmaceuticals Ltd on:<br />

Tel: +44 (0)1895 826 606 Email: medinfo@norgine.com<br />

References: 1. Bisschops R, et al. Endoscopy 2018; doi: 10.1055/a-0638-8125. 2. Schreiber S, et al. Endoscopy 2018; doi: 10.1055/a-0639-5070. 3. DeMicco MP, et al. Gastrointest Endosc 2018; doi: 10.1016/j.gie.2017.07.047. 4. PLENVU ® UK Summary of Product<br />

Characteristics. October 2018. 5. MOVIPREP ® UK Summary of Product Characteristics. September 2018. 6. MOVIPREP ® Orange UK Summary of Product Characteristics. August 2017.<br />

UK/PLV/0519/0164<br />

Date of preparation: May <strong>2019</strong><br />

Ireland<br />

Healthcare professionals are asked to report any suspected<br />

adverse reactions via HPRA Pharmacovigilance, Earlsfort<br />

Terrace, IRL - Dublin 2; Tel: +353 1 6764971;<br />

Fax: +353 1 6762517.<br />

Website: www.hpra.ie; E-mail: medsafety@hpra.ie.<br />

Adverse events should also be reported to Norgine<br />

Pharmaceuticals Ltd on:<br />

Tel: +44 (0)1895 826 606 Email: medinfo@norgine.com


Moviprep and Moviprep Orange (Macrogol 3350, sodium sulphate,<br />

ascorbic acid, sodium ascorbate and electrolytes) Prescribing<br />

Information<br />

REFER TO THE SUMMARY OF PRODUCT CHARACTERISTICS (SmPC)<br />

BEFORE PRESCRIBING<br />

Presentation: A box containing two transparent bags, each containing<br />

two separate sachets, A and B. Sachet A contains macrogol 3350 100g;<br />

sodium sulphate anhydrous 7.5g; sodium chloride 2.691g and potassium<br />

chloride 1.015g as white to yellow powder. Sachet B contains ascorbic acid<br />

4.7g and sodium ascorbate 5.9g as white to light brown powder. Moviprep<br />

also contains aspartame (E951), acesulfame potassium (E950) and a lemon<br />

or orange flavour. Uses: Bowel cleansing prior to any clinical procedure<br />

requiring a clean bowel. Dosage and administration: Adults and Older<br />

People: A course of treatment consists of two litres of Moviprep. A litre of<br />

Moviprep consists of one Sachet A and one Sachet B dissolved together<br />

in water to make one litre. This one litre reconstituted solution should be<br />

drunk over a period of one to two hours. This process should be repeated<br />

with a second litre of Moviprep to complete the course. A further litre of<br />

clear fluid is recommended during the course of treatment. This course of<br />

treatment can be taken either as divided or as single doses and timing is<br />

dependent on whether the clinical procedure is conducted with or without<br />

general anaesthesia as specified below: For procedures conducted<br />

under general anaesthesia: 1. Divided doses: one litre of Moviprep in<br />

the evening before and one litre of Moviprep in the early morning of the<br />

day of the clinical procedure. Ensure consumption of Moviprep as well as<br />

any other clear fluids has finished at least two hours before the start of the<br />

clinical procedure. 2. Single dose: two litres of Moviprep in the evening<br />

before the clinical procedure or two litres of Moviprep in the morning of the<br />

clinical procedure. Ensure consumption of Moviprep as well as any other<br />

clear fluids has finished at least two hours before the start of the clinical<br />

procedure. For procedures conducted without general anaesthesia:<br />

1. Divided doses: one litre of Moviprep in the evening before and one litre of<br />

Moviprep in the early morning of the day of the clinical procedure. Ensure<br />

consumption of Moviprep as well as any other clear fluids has finished at<br />

least one hour before the start of the clinical procedure. 2. Single dose: two<br />

litres of Moviprep in the evening before the clinical procedure or two litres<br />

of Moviprep in the morning of the clinical procedure. Ensure consumption<br />

of Moviprep has finished at least two hours before the start of the clinical<br />

procedure. Ensure consumption of any clear fluids has finished at least<br />

one hour before the clinical procedure. Patients should be advised to<br />

allow for appropriate time to travel to the colonoscopy unit. No solid food<br />

should be taken from the start of the course of treatment until after the<br />

clinical procedure. Children: Not recommended in children below 18 years<br />

of age. Contra-indications, warnings etc: Contra-indications: Known<br />

or suspected hypersensitivity to any of the ingredients, gastrointestinal<br />

obstruction or perforation, disorders of gastric emptying, ileus,<br />

phenylketonuria, glucose-6-phosphate dehydrogenase deficiency, toxic<br />

megacolon which complicates very severe inflammatory conditions of the<br />

intestinal tract. Do not use in unconscious patients. Warnings: Diarrhoea is<br />

an expected effect. Administer with caution to fragile patients in poor health<br />

or patients with serious clinical impairment such as impaired gag reflex,<br />

or with a tendency to aspiration or regurgitation, impaired consciousness,<br />

severe renal insufficiency, cardiac impairment (NYHA grade III or IV), those at<br />

risk of arrhythmia, dehydration, severe acute inflammatory bowel disease.<br />

Dehydration, if present, should be corrected before using Moviprep. The<br />

reconstituted Moviprep does not replace regular fluid intake and adequate<br />

fluid intake must be maintained. Semi-conscious patients or patients prone<br />

to aspiration should be closely monitored during administration, particularly<br />

if this is via a naso-gastric route. If symptoms indicating arrhythmia or shifts<br />

of fluid or electrolytes occur, plasma electrolytes should be measured,<br />

ECG performed and any abnormality treated appropriately. In debilitated<br />

fragile patients, patients with poor health, those with clinically significant<br />

renal impairment, arrhythmia and those at risk of electrolyte imbalance,<br />

the physician should consider performing baseline and post-treatment<br />

electrolyte, renal function test and ECG as appropriate. The possibility<br />

of serious arrhythmias, predominantly in those with underlying cardiac<br />

risk factors and electrolyte disturbance cannot be ruled out. If patients<br />

experience symptoms which make it difficult to continue the preparation,<br />

they may slow down or temporarily stop consuming the solution and should<br />

consult their doctor. Moviprep containing orange flavour is not recommended<br />

for patients with glucose and galactose malabsorption. Moviprep contains<br />

56.2 mmol of absorbable sodium per litre (caution in patients on a<br />

controlled sodium diet), 14.2 mmol potassium per litre (caution in patients<br />

with reduced kidney function or patients on a controlled potassium diet).<br />

Interactions: Oral medication should not be taken within one hour of<br />

administration as it may be flushed from the GI tract and not absorbed.<br />

Pregnancy and lactation: There is no experience of use in pregnancy or<br />

lactation so it should only be used if judged essential by the physician. Side<br />

Effects: Very common or common: abdominal pain, nausea, abdominal<br />

distension, anal discomfort, malaise, pyrexia, vomiting, dyspepsia, hunger,<br />

thirst, sleep disorder, headache, dizziness, and rigors. Uncommon or<br />

unknown: Dysphagia, discomfort, abnormal liver function tests, allergic<br />

reactions including rash, urticaria, pruritus, erythema, angioedema and<br />

anaphylaxis, dyspnoea, electrolyte disturbances, dehydration, convulsions<br />

associated with severe hyponatraemia, transient increase in blood pressure,<br />

arrhythmia, palpitations, flatulence and retching. Refer to the Summary of<br />

Product Characteristics (SmPC) for full list and frequency of adverse events.<br />

Overdose: In case of gross accidental overdosage, conservative measures<br />

are usually sufficient. In the rare event of severe metabolic derangement,<br />

intravenous rehydration may be used. Pharmaceutical Particulars:<br />

Sachets: Store in the original package below 25°C. Reconstituted solution:<br />

Keep covered. May be stored for up to 24 hours below 25°C or in a<br />

refrigerator. Legal Category: UK – Pharmacy only, Ireland - Prescription<br />

medicine. Packs: One pack of Moviprep or Moviprep Orange contains a<br />

single treatment. Basic NHS Price: UK £10.36, Ireland €13.26 Marketing<br />

Authorisation Number: UK: PL 20142/0005 (Moviprep), PL 20011/0006<br />

(Moviprep Orange). IE: PA 1336/1/1(Moviprep), PA 1336/1/2 (Moviprep<br />

Orange). For further information contact: Norgine Pharmaceuticals Ltd,<br />

Moorhall Road, Harefield, Middlesex UB9 6NS Tel: +44 (0) 1895 826606<br />

E-mail: medinfo@norgine.com Date of preparation/revision: March 2018.<br />

Ref UK/MPR/0318/0182<br />

United Kingdom Adverse events should be reported. Reporting forms<br />

and information can be found at www.mhra.gov.uk/yellowcard.<br />

Adverse events should also be reported to Medical Information at<br />

Norgine Pharmaceuticals Ltd on 01895 826606.<br />

Ireland Healthcare professionals are asked to report any suspected<br />

adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace,<br />

IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.<br />

Website: www.hpra.ie; E-mail: medsafety@hpra.ie.<br />

Norgine Adverse events should also be reported to<br />

Medical Information at Norgine Pharmaceuticals on +44 1895 826606<br />

or E-mail: medinfo@norgine.com<br />

PLENVU, MOVIPREP, NORGINE and<br />

the sail logo are registered trademarks<br />

of the Norgine group of companies.<br />

NVU UK IRE GASTRO TODAY JUNE AD 210x297_FINAL.indd 23/05/<strong>2019</strong> 11:11 2<br />

Raising the bar for IBD<br />

care - launch of <strong>2019</strong> IBD<br />

Standards<br />

By Rukshana Kapasi, Chair of IBD UK<br />

The <strong>2019</strong> BSG conference sees the launch<br />

of the revised UK-wide IBD Standards, new<br />

exciting guidelines which could lead to<br />

drastic changes in how we care for people<br />

with Crohn’s or Colitis.<br />

These build on the previous IBD Standards<br />

(published in 2009 and updated in 2013)<br />

and have been devised by IBD UK, a<br />

partnership of 17 patient and professional<br />

organisations, including the British Society of<br />

<strong>Gastroenterology</strong>, Royal College of Nursing,<br />

Crohn’s & Colitis UK, CIRCA and Ileostomy<br />

Association, who are working together for<br />

everyone affected by Inflammatory Bowel<br />

Disease.<br />

The first audit of IBD Services in 2006<br />

highlighted wide variation in the quality and<br />

consistency of care for people with Crohn’s<br />

and Colitis, and whilst significant improvements<br />

have been made, this is unfortunately still the<br />

case. Not only this, the way we care for people<br />

with Crohn’s and Colitis has changed in the<br />

intervening years, with new therapy options, and<br />

a shift to self-management and personalised<br />

care and support.<br />

This version of the standards has seen a<br />

transformation, putting the patient at the centre<br />

and ensuring that everything we are asking for<br />

will ultimately make a difference to people with<br />

the conditions.<br />

When revising the standards, it was also<br />

important for us to consider technological<br />

advances, which have led to a huge change<br />

in the way we treat patients. Alongside this,<br />

society now takes a more holistic view towards<br />

care, not just for people with Crohn’s and<br />

Colitis, but across condition areas.<br />

The <strong>2019</strong> IBD Standards are a framework<br />

of statements that define what should be<br />

put in place to deliver safe, high-quality,<br />

personalised care for people with Crohn’s and<br />

Colitis. They cover all stages of the patient<br />

journey: pre-diagnosis, newly diagnosed,<br />

flare management, surgery, inpatient care and<br />

ongoing care, and how the IBD service should<br />

NEWS<br />

be organised to deliver this. The Standards<br />

complement the recently published BSG and<br />

ACPGBI IBD guidelines.<br />

All IBD Services should be working towards<br />

delivering the IBD Standards and the IBD UK<br />

website will house guidance and resources<br />

to help services implement these. Also being<br />

launched is a benchmarking tool which<br />

will allow the IBD Service to compare its<br />

performance against the standards, as well as<br />

with other services.<br />

It is important to note that benchmarking is an<br />

extremely positive tool for IBD Services – as<br />

well as highlighting the things they are doing<br />

brilliantly at; it can be an opportunity to push<br />

through some real changes. It is designed<br />

to help with putting together business cases<br />

based on empirical evidence, to make the best<br />

use of resources and establish priorities.<br />

From the launch date in June to August, one<br />

person from the IBD Service (representing<br />

the team) can register to sign up the<br />

benchmarking tool on the IBD UK website. The<br />

period of September to December is when the<br />

tool will need to be filled out. This will involve<br />

answering questions that align with the IBD<br />

Standards statements.<br />

Alongside this, IBD UK, supported by Crohn’s<br />

& Colitis UK, will be launching the first UK-wide<br />

IBD patient survey to ensure that the patient<br />

perspective is central, and that the patient<br />

experience helps shape the IBD service.<br />

People with Crohn’s and Colitis will be able to<br />

anonymously feedback on the Service.<br />

The benchmarking tool together with the<br />

patient survey are valuable tools that will<br />

enable IBD Services to be more effective<br />

with their team and efficient with resources<br />

and finances. This is an exciting and ground<br />

breaking opportunity for services and patients<br />

to work collaboratively leading to the shared<br />

priority of improving the lives of people with<br />

Crohn’s and Colitis.<br />

The Standards have been produced by<br />

patients and professionals working together<br />

and it is fundamental that this partnership<br />

approach continues to make them a reality.<br />

We need everybody to get involved to<br />

make a difference. To find out more about<br />

the IBD Standards and to register for the<br />

benchmarking tool visit ibduk.org.uk<br />

GASTROENTEROLOGY TODAY - SUMMER <strong>2019</strong><br />

17


NEWS<br />

ARE YOU DOING YOUR BEST<br />

FOR PBC PATIENTS?<br />

Inadequate or intolerant response to UDCA is defined as<br />

ALP >1.67 x ULN (>200 IU/L) and/or bilirubin 2 x ULN 1<br />

1<br />

PBC expertise is closer<br />

than you think...<br />

Consider referral to 1 of 26<br />

PBC hubs in the UK comprised<br />

of specialist multidisciplinary<br />

teams for individualised patient<br />

treatment and second line therapy.<br />

6<br />

3 4<br />

2<br />

26<br />

11<br />

32<br />

15<br />

9<br />

7<br />

24<br />

23<br />

16<br />

17<br />

12<br />

13<br />

25<br />

21 8<br />

14<br />

Find your nearest PBC referral<br />

hub at www.uk-pbc.com/<br />

newtherapiesinpbc/<br />

5<br />

31<br />

28<br />

29<br />

18<br />

22<br />

10<br />

20<br />

27 19<br />

Liver Centres<br />

PBC Hubs<br />

30<br />

1. Aberdeen Royal Infirmary<br />

2. Ninewells Hospital, Dundee<br />

3. Glasgow Royal Infirmary<br />

4. Edinburgh Royal Infirmary<br />

5. University Hospital Wales,<br />

Cardiff<br />

6. Royal Victoria Hospital,<br />

Belfast<br />

7. Aintree Univ Hosp NHS FT<br />

8. Barts Health NHS Trust<br />

9. Bradford Teaching<br />

10. Cambridge Univ Hosp<br />

NHS FT<br />

11. East Lancashire Hosps<br />

NHS Trust<br />

12. Hull & East Yorkshire<br />

NHS Trust<br />

13. King’s College Hosp<br />

NHS FT<br />

14. Imperial College<br />

Healthcare Trust<br />

15. Leeds Teaching Hosp<br />

NHS Trust<br />

16. Manchester University<br />

NHS FT<br />

17. Nottingham Univ Hosp<br />

NHS Trust<br />

18. Oxford Univ Hosps<br />

NHS FT<br />

19. Portsmouth Hosps<br />

NHS Trust<br />

20. Royal Devon & Exeter FT<br />

21. Royal Free London NHS FT<br />

22. Royal Surrey County Hosp<br />

NHS FT<br />

23. Royal L’pool/Broadgreen<br />

Univ Trust<br />

24. Sheffield Teaching<br />

Hosp FT<br />

25. St George’s Univ Hosps<br />

NHS FT<br />

26. The Newcastle upon Tyne<br />

Hosps FT<br />

27. Univ Hosp Southampton<br />

NHS FT<br />

28. Univ Hosps Birmingham<br />

NHS FT<br />

29. Univ Hosps Leicester<br />

NHS Trust<br />

30. Univ Hosps Plymouth<br />

NHS Trust<br />

31. University Hosp Bristol<br />

NHS FT<br />

32. York Teaching Hospital<br />

NHS FT<br />

Find out more information in the BSG guidelines at www.bsg.org.uk/clinical/bsg-guidelines.html<br />

GASTROENTEROLOGY TODAY - SUMMER <strong>2019</strong><br />

Abbreviated Prescribing Information<br />

OCALIVA ® (obeticholic acid)<br />

(Please refer to the Full Summary of Product Characteristics (SmPC) before prescribing)<br />

Presentation: OCALIVA supplied as film-coated tablets containing 5 mg<br />

and 10 mg obeticholic acid. Indication: For the treatment of primary<br />

biliary cholangitis (also known as primary biliary cirrhosis) in combination<br />

with ursodeoxycholic acid (UDCA) in adults with an inadequate response<br />

to UDCA or as monotherapy in adults unable to tolerate UDCA. Dosage<br />

and administration: Oral administration. Hepatic status must be known<br />

before initiating treatment. In patients with normal or mildly impaired<br />

(Child Pugh Class A) hepatic function, the starting dose is 5 mg once<br />

daily. Based on an assessment of tolerability after 6 months, the dose<br />

should be increased to 10 mg once daily if adequate reduction of alkaline<br />

phosphatase (ALP) and/or total bilirubin have not been achieved. No<br />

dose adjustment of concomitant UDCA is required in patients receiving<br />

obeticholic acid. For cases of severe pruritus, dose management includes<br />

reduction, temporal interruption or discontinuation for persistent<br />

intolerable pruritus; use of bile acid binding agents or antihistamines<br />

(see SmPC). Moderate to Severe Hepatic Impairment: In patients with<br />

Child-Pugh B or C hepatic impairment, a reduced starting dose of 5mg<br />

once weekly is required. After 3 months, depending on response and<br />

tolerability, the starting dose may be titrated to 5 mg twice weekly and<br />

subsequently to 10 mg twice weekly (at least 3 days between doses)<br />

if adequate reductions in ALP and/or total bilirubin have not been<br />

achieved. No dose adjustment required in Child Pugh Class A function.<br />

Mild or moderate renal impairment: No dose adjustments are required.<br />

Paediatric population: No data. Elderly: No dose adjustment required;<br />

limited data exists. Contraindications: Hypersensitivity to the active<br />

substance or any excipients. Complete biliary obstruction. Special<br />

warnings and precautions for use: After initiation, patients should be<br />

monitored for progression of PBC with frequent clinical and laboratory<br />

assessment of those at increased risk of hepatic decompensation. Dose<br />

frequency should be reduced in patients who progress from Child Pugh<br />

A to Child Pugh B or C Class disease. Serious liver injury and death have<br />

been reported in patients with moderate/severe impairment who did not<br />

receive appropriate dose reduction. Liver-related adverse events have<br />

been observed within the first month of treatment and have included<br />

elevations in alanine amino transferase (ALT), aspartate aminotransferase<br />

(AST) and hepatic decompensation. Interactions: Following coadministration<br />

of warfarin and obeticholic acid, International Normalised<br />

Ratio (INR) should be monitored and the dose of warfarin adjusted, if<br />

needed, to maintain the target INR range. Therapeutic monitoring of<br />

CYP1A2 substrates with narrow therapeutic index (e.g. theophylline and<br />

tizanidine) is recommended. Obeticholic acid should be taken at least<br />

4-6 hours before or after taking a bile acid binding resin, or at as great<br />

an interval as possible. Fertility, pregnancy and lactation: Avoid use in<br />

pregnancy. Either discontinue breast-feeding or discontinue/abstain from<br />

obeticholic acid therapy taking into account the benefit of breast-feeding<br />

for the child and the benefit of therapy for the woman. No clinical data<br />

on fertility effects. Undesirable effects: Very common (≥1/10) adverse<br />

reactions were pruritus, fatigue, and abdominal pain and discomfort. The<br />

most common adverse reaction leading to discontinuation was pruritus.<br />

The majority of pruritus occurred within the first month of treatment<br />

and tended to resolve over time with continued dosing. Other commonly<br />

(≥ 1/100 to < 1/10) reported adverse reactions are, thyroid function<br />

abnormality, dizziness, palpitations, oropharyngeal pain, constipation,<br />

eczema, rash, arthralgia, peripheral oedema, and pyrexia. Please refer to<br />

the SmPC for a full list of undesirable effects. Overdose: Liver-related<br />

adverse reactions were reported with higher than recommended doses of<br />

obeticholic acid. Patients should be carefully observed, and supportive<br />

care administered, as appropriate.<br />

Legal category: POM<br />

Marketing authorisation numbers: EU/1/16/1139/001 & 002 Marketing<br />

authorisation holder: Intercept Pharma Ltd,<br />

2 Pancras Square, London, N1C 4AG, United Kingdom Package<br />

Quantities and Basic NHS cost: OCALIVA 5 mg and 10 mg £2,384.04<br />

per bottle of 30 tablets.<br />

Date of revision: 11th April 2018<br />

Adverse events should be reported. Reporting forms and<br />

information can be found at www.mhra.gov.uk/yellowcard.<br />

Adverse events should also be reported to<br />

Intercept Pharma Ltd on +44 (0)330 100 3694<br />

or email: drugsafety@interceptpharma.com<br />

18<br />

ALP, alkaline phosphatase; PBC, primary biliary cholangitis, UDCA, ursodeoxycholic acid; ULN, upper limit of normal.<br />

1. EASL guidelines. J Hepatol. 2017;67:145–172<br />

UK-PP-PB-0376 May <strong>2019</strong>


NEWS<br />

New biosimilar safety<br />

monitoring initiative in IBD<br />

The introduction of biological treatments<br />

has made a significant difference in the<br />

lives of many IBD patients. The advent of<br />

multiple biosimilars (generic medicines that<br />

are biologically similar to the originator)<br />

increases the affordability and so availability<br />

of these life-changing treatments.<br />

How can sites participate?<br />

We are starting our monitoring of biosimilars<br />

with Hyrimoz (adalimumab), with Zessly<br />

(infliximab) coming soon.<br />

If your IBD service is using one of these<br />

biosimilars, please get in touch with us if you<br />

would like to participate in these important<br />

studies. The wider the data collection, the<br />

more closely it reflects real-world effects,<br />

so we encourage you to join with us to gather<br />

the evidence.<br />

We will be initiating a number of similar studies<br />

shortly.<br />

For further information or to get involved<br />

please contact the IBD Registry email:<br />

support@ibdregistry.org.uk<br />

Tel 020 3393 3969<br />

A primary aim of the IBD Registry is to help<br />

improve the quality of life for people with IBD,<br />

by using our UK-wide reach to collect and<br />

analyse relevant data. With over 54,000 patient<br />

records, the UK IBD Registry is one of the<br />

largest IBD registries in Europe.<br />

The recent introduction of biosimilar medicines<br />

has placed the Registry in a key position to<br />

facilitate the collection of crucial, on-going<br />

safety data as these treatments become more<br />

widely used.<br />

We are pleased to announce that the<br />

Registry will soon be facilitating a series of<br />

observational post market authorisation safety<br />

studies using our existing web-based data<br />

collection systems. Our first study will monitor<br />

the use of Hyrimoz, an adalimumab biosimilar,<br />

produced by Sandoz. The study is part of<br />

routine clinical care, but patients will be asked<br />

to consent to their data being used in the<br />

study.<br />

GI COGNITION<br />

THE MOBILE GI PHYSIOLOGY<br />

TEL: 0780 8562476<br />

INFO@GI-COGNITION.COM<br />

ANY HOSPITAL, ANYWHERE IN THE UK<br />

MOBILE DIAGNOSTIC BENEFITS<br />

• Dramatic reduction in waiting list.<br />

• Available in ALL areas of the UK.<br />

• Competitively priced, instantly cut in spending.<br />

• High standard of service and accurate reporting.<br />

• Less travelling for patients.<br />

WHO WILL BENEFIT?<br />

• Patients<br />

• Gastroenterologists<br />

• General Surgeons<br />

• Chest Specialists<br />

• ENT Specialists<br />

• GI Physiology Units<br />

• ….. Patients<br />

HOW DOES IT WORK?<br />

• Hospitals book their patients in<br />

their facility.<br />

• GI Cognition take equipment,<br />

do the tests, report.<br />

Regulated By CQC and Registered With ICO<br />

GASTROENTEROLOGY TODAY - SUMMER <strong>2019</strong><br />

19


NEWS<br />

National charity Coeliac UK<br />

and Innovate UK announce<br />

£750k boost to research that<br />

unlocks gluten free challenges<br />

Coeliac UK, the national charity for<br />

people who need to live gluten free, has<br />

combined forces with Innovate UK, the UK’s<br />

innovation agency, to drive improvements<br />

worth £750,000 in the food technology,<br />

diagnostics and digital care industries.<br />

The funding will support projects based in<br />

Birmingham, Newcastle and Edinburgh and is<br />

part of Innovate UK’s partnership with the third<br />

sector on health research projects, bringing direct<br />

benefits to both patients and UK businesses.<br />

The UK has been at the forefront of the most<br />

dynamic growth area in free from food retailing<br />

and Coeliac UK is the world’s largest support<br />

organisation for people with coeliac disease.<br />

This collaboration will build on these strengths by<br />

Sarah Sleet, chief executive of Coeliac UK<br />

said: “Coeliac UK is a world leader on coeliac<br />

disease, supporting research that makes a<br />

real world impact. This new research to create<br />

a different diagnostic test could help unlock<br />

a worldwide problem for millions of people<br />

without a proper diagnosis of coeliac disease,<br />

while the research on innovative gluten free<br />

ingredients will keep the UK ahead in the food<br />

industry’s expansion into gluten free. Meanwhile<br />

our third funded project could offer real savings<br />

to the NHS in the management of the lifelong<br />

autoimmune condition that is coeliac disease<br />

providing a service model for the many other<br />

chronic long term conditions in the UK.”<br />

Dr Kath Mackay, Director of Ageing Society,<br />

Health and Nutrition at Innovate UK, said:<br />

“Stimulating innovation in our food and<br />

health sectors are crucial components of the<br />

government’s industrial strategy. By working<br />

with Coeliac UK we will be able to offer funding<br />

that results in improved quality of life for<br />

people with this condition and support and<br />

stimulate our vibrant health care and food<br />

technology sectors.”<br />

supporting research advances in food technology,<br />

Gastro<strong>Today</strong>_Jan_<strong>2019</strong>_v4 26/01/<strong>2019</strong> 09:39 Page 1<br />

diagnostic techniques and digital care.<br />

The three projects reflect the key challenges<br />

of living with coeliac<br />

disease and a gluten<br />

free life:<br />

New test to provide<br />

a less invasive<br />

way of diagnosing<br />

coeliac disease<br />

- Nonacus Ltd,<br />

Birmingham<br />

new test will rely on a proprietary laboratory<br />

test in conjunction with a patented computer<br />

algorithm. It’s a completely new way of looking<br />

at the immune cells and can identify patients<br />

with coeliac disease by predicting how likely<br />

immune cells are to be responding to gluten.<br />

It aims to develop a coeliac disease test for<br />

people who have already adopted a gluten<br />

free diet, as well as an improvement on the<br />

current method of analysing biopsy samples.<br />

This will not only save considerable patient<br />

suffering but will also provide savings to the<br />

NHS speeding up diagnosis journeys.<br />

Development of three new plant proteins to<br />

help improve the ingredients used in gluten<br />

free bread - Nandi Proteins Ltd, Scotland<br />

To improve gluten free bread by developing<br />

revolutionary new ingredients. Nandi Proteins<br />

Ltd (a protein technology company), Genius<br />

Foods (gluten free food manufacturer) AB Mauri<br />

(distributor of bakery ingredients) and Agrii (a<br />

plant science and technology company) will join<br />

researchers at Heriot Watt University to develop<br />

three kinds of new plant proteins. The proteins<br />

will be derived from crops which are underused<br />

in the UK: rapeseed cake, faba beans and<br />

naked oats. These new ingredients could<br />

replace the expensive egg and dairy based<br />

ingredients currently used, improve the nutrient<br />

profile, taste and texture of gluten free bread<br />

and reduce the need for E number additives.<br />

Development of these new ingredients will<br />

also open up new markets for UK grown crops<br />

and add value to the UK economy. Overall<br />

consumers could see cheaper and better<br />

quality gluten free products.<br />

GASTROENTEROLOGY TODAY - SUMMER <strong>2019</strong><br />

The average time<br />

to gain a coeliac<br />

disease diagnosis is<br />

13 years and there<br />

are half a million<br />

people in the UK<br />

undiagnosed – and<br />

in the tens of millions<br />

worldwide. Nonacus<br />

Ltd, working with<br />

researchers at<br />

the University of<br />

Cambridge led by Dr<br />

Elizabeth Soilleux,<br />

will together develop<br />

a test for coeliac<br />

disease. Current<br />

tests only work if<br />

patients are still<br />

eating gluten. The<br />

Software innovation to help in the ongoing<br />

management of coeliac disease - Cievert<br />

Ltd, Newcastle<br />

Software will be developed to better manage<br />

coeliac disease. Working with leading<br />

researchers from Sheffield University, the goal<br />

is to find patients with coeliac disease that need<br />

more support, compared to those who are living<br />

well. The software, when developed, will let<br />

people receive the assurance of being clinically<br />

followed up without the inconvenience, time and<br />

cost of hospital appointments. Whilst those who<br />

need additional care will be identified quickly<br />

and easily so that they can access crucial<br />

support when they need it most. This could be<br />

technology that is applied to other conditions<br />

in the future resulting in substantial savings for<br />

the NHS.<br />

20


IMPROVING QUALITY IN<br />

NEWS<br />

DIAGNOSTIC ENDOSCOPY<br />

WITH 18 WEEK SUPPORT<br />

th<br />

Standards in colonoscopy have improved<br />

greatly over the last decade although there<br />

is still variability in the adenoma detection<br />

rates (ADR) and cancer miss rates across<br />

the UK. The bowel cancer screening program<br />

has also helped to improve standards with<br />

the introduction of competency assessment.<br />

Upper GI endoscopy however has fallen<br />

behind and cancer miss rates in the upper<br />

gastrointestinal tract remain far too high<br />

reaching between 10% and over 20%.<br />

How can we continue to improve diagnostic<br />

performance?<br />

The Endoscopy Quality Improvement Program<br />

(EQIP) for colonoscopy and endoscopy<br />

is being rolled out across the UK and has<br />

had excellent feedback from delegates.<br />

Furthermore, there is evolving evidence that<br />

training bundles are effective in improving<br />

ADR, in particular the use of position change,<br />

cleansing agents, muscular relaxants<br />

and extended withdrawal. There are other<br />

techniques which improve polyp detection<br />

including the Endocuff Vision and water<br />

exchange colonoscopy. At 18 Weeks our<br />

nurses independently measure withdrawal<br />

times and routinely polyp spot to try and<br />

improve the ADR.<br />

about Endoscopy?<br />

18 Week Support<br />

nce<br />

has<br />

00<br />

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n<br />

rces<br />

The technical aspects of upper GI endoscopy<br />

that are likely to improve the detection and<br />

diagnostic accuracy of pathology include<br />

the use of cleansing agents, in particular<br />

simethicone and N-acetyl cysteine as a<br />

mucolytic. Buscopan can aid in gastric<br />

Endoscopy views, as can services adequate gastric insufflation<br />

Our as small specialist cancers Endoscopy can hide insourcing behind gastric<br />

services folds. In have addition, been there developed is evidence to support to support<br />

NHS endoscopic trusts with: inspection time for example the<br />

Barretts 2WW Urgent inspection referrals time (BIT) taking 1 minute<br />

to Routine view each referrals 1cm of Barretts, as well as 7<br />

minutes Surveillance for the cases pre-cancerous stomach.<br />

Bowel cancer screening services<br />

The Enhanced above mentioned sedation (Propofol) techniques lists allow<br />

enhanced mucosal visualisation, however the<br />

Additionally, endoscopist we also can needs support the Direct skills to Access detect<br />

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working eyes only with sees the what local the clinical mind leads is prepared to agree to<br />

strong comprehend, governance and for thus the pattern management recognition of<br />

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Criteria of recent & studies Qualitydemonstrating how detection<br />

We and select characterisation Endoscopists skills with can endoscopy be improved<br />

orientated career path and performance<br />

measures above the national average. JAG<br />

audit data is constantly monitored to ensure<br />

through image and videos based training<br />

modules. These modules can easily be<br />

viewed remotely and have the potential to<br />

improve performance both for upper and lower<br />

endscopy.<br />

18 Weeks is planning to roll out video and<br />

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for 18 Weeks nurses and consultants which<br />

will be opened up to all UK based staff. Our<br />

aim is to improve endoscopic detection and<br />

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Endoscopy services<br />

Our specialist Endoscopy insourcing services<br />

have been developed to support NHS trusts<br />

with:<br />

• 2WW Urgent referrals<br />

• Routine referrals<br />

• Surveillance cases<br />

• Bowel cancer screening services<br />

• Enhanced sedation (Propofol) lists<br />

Raising the standard of care<br />

Our clinical teams are committed to<br />

Criteria & Quality<br />

working weekends to provide a wide range<br />

We select Endoscopists with an endoscopy<br />

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measures above the national average. JAG<br />

patients benefit from the work our teams do,<br />

audit data is constantly monitored to ensure<br />

there is also an opportunity for NHS Trust<br />

ongoing quality. Furthermore, we have a<br />

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techniques or approaches.<br />

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Who we’re looking for<br />

We are interested in meeting with Consultant<br />

to maintaining quality and safety but also<br />

provides support to both Endoscopists and<br />

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Raising the standard of care<br />

Our clinical teams are committed to working<br />

weekends to provide a wide range of clinical<br />

services. Many of our clinical leads are experts<br />

in their field. So not only do patients benefit<br />

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Who we’re looking for<br />

We are interested in meeting with Consultant<br />

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nurse specialists throughout the UK.<br />

Our remuneration package is second to none<br />

and is per session rather than per case which<br />

allows our teams to work in a safe and calm<br />

environment’<br />

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want to help clear NHS waiting list backlogs,<br />

reduce RTT waiting times and provide<br />

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GASTROENTEROLOGY TODAY - SUMMER <strong>2019</strong><br />

21


NEWS<br />

Is your IBS actually<br />

undiagnosed coeliac<br />

disease?<br />

• 97%¹ of people don’t realise IBS symptoms<br />

could be coeliac disease<br />

• 1 in 4 people with coeliac disease were<br />

previously misdiagnosed with IBS<br />

• Half a million people in the UK are living with<br />

coeliac disease without knowing it<br />

With only 3% 1 of British adults aware that the<br />

symptoms of IBS (irritable bowel syndrome)<br />

are also common symptoms of coeliac<br />

disease, national charity Coeliac UK, is<br />

calling on greater awareness of the similarity<br />

of symptoms and urges anyone with IBS to<br />

ask their GP for a coeliac disease blood test,<br />

if they have not already had one.<br />

policy, research and campaigns said: “It is<br />

essential that awareness of the similarity of the<br />

symptoms increases and that GPs adhere to<br />

the NICE (National Institute for Health and Care<br />

Excellence) guideline which states that anyone<br />

with IBS symptoms should be tested for coeliac<br />

disease before a diagnosis of IBS is made.”<br />

Coeliac disease is not an allergy or an<br />

intolerance but an autoimmune disease where<br />

the body’s immune system damages the lining<br />

of the small bowel when gluten, a protein<br />

(found in wheat, barley and rye) is eaten.<br />

There is no cure and no medication; the only<br />

treatment is a strict gluten free diet for life.<br />

1 in 100 people in the UK is estimated to<br />

have coeliac disease but of these, only 30%<br />

are currently diagnosed, meaning there are<br />

nearly half a million people in the UK with<br />

undiagnosed coeliac disease.<br />

gluten ataxia and neuropathy, and although<br />

rare, there is an increased risk of small bowel<br />

cancer and intestinal lymphoma.<br />

“The first step to diagnosing coeliac disease is<br />

a simple, inexpensive blood test done in primary<br />

care, but thousands of people are not getting the<br />

necessary testing and are being left undiagnosed<br />

including those with IBS symptoms. This not<br />

only causes years of unnecessary suffering but<br />

also wasted costs to the NHS with repeated<br />

appointments and investigations.<br />

We urge anyone who has symptoms such as<br />

ongoing bloating, diarrhoea or constipation<br />

and has been given a diagnosis of IBS but not<br />

been tested for coeliac disease to ask their GP<br />

to test them for coeliac disease. However, it is<br />

essential to keep eating gluten until all tests are<br />

completed as otherwise these tests may give a<br />

false negative result,” continued Ms McGough.<br />

As many as 1 in 4 people with coeliac disease<br />

were previously misdiagnosed with IBS<br />

as many of the symptoms for IBS such as<br />

bloating, stomach pains or cramps, diarrhoea<br />

or constipation and feeling exhausted are the<br />

same as the symptoms of coeliac disease.<br />

Norma McGough Coeliac UK director of<br />

The average time it takes for someone to<br />

get a diagnosis is 13 years from the onset of<br />

symptoms; by which time, they may already be<br />

suffering with added complications caused by<br />

the disease. If left untreated, coeliac disease<br />

can lead to a number of serious complications,<br />

including: anaemia, osteoporosis, unexplained<br />

infertility, neurological conditions such as<br />

Coeliac UK’s online assessment www.coeliac.<br />

org.uk/isitcoeliacdisease, based on the NICE<br />

guideline NG20, gives people greater confidence<br />

to seek further medical advice from their GP.<br />

Upon completion of the assessment, the<br />

respondent will receive an email with their results,<br />

which will indicate whether their symptoms are<br />

potentially linked to coeliac disease.<br />

WHY NOT WRITE FOR US?<br />

GASTROENTEROLOGY TODAY - SUMMER <strong>2019</strong><br />

<strong>Gastroenterology</strong> <strong>Today</strong> welcomes the submission of<br />

clinical papers and case reports or news that<br />

you feel will be of interest to your colleagues.<br />

Material submitted will be seen by those working within all<br />

UK gastroenterology departments and endoscopy units.<br />

All submissions should be forwarded to info@mediapublishingcompany.com<br />

If you have any queries please contact the publisher Terry Gardner via:<br />

info@mediapublishingcompany.com<br />

22<br />

1<br />

Reference YouGov Survey<br />

When answering the question: ‘What do you think are common symptoms of coeliac disease?’, only 3% of respondents answered IBS symptoms.<br />

All figures, unless otherwise stated, are from YouGov Plc. Total sample size was 8423 adults. Fieldwork was undertaken between 20th December 2018 - 2nd January <strong>2019</strong>.<br />

The survey was carried out online. The figures have been weighted and are representative of all GB adults (aged 18+).


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23


NEWS<br />

suicide is higher in the first six months<br />

unaddressed can have a huge detrimental<br />

Half of patients with<br />

deadliest common cancer<br />

have unmet support needs,<br />

first ever UK survey reveals<br />

of diagnosis and particularly for patients<br />

whose cancer had spread to other organs,<br />

underlining the importance of patients<br />

receiving specialist psychological care as<br />

early as possible.<br />

impact on their quality of life. Pancreatic<br />

cancer is a complex disease that can<br />

progress devastatingly quickly, often<br />

leaving those affected with little time with<br />

their loved ones. We want to see support<br />

needs assessed for all pancreatic cancer<br />

GASTROENTEROLOGY TODAY - SUMMER <strong>2019</strong><br />

Physical and psychological support need<br />

of patients with the deadliest common<br />

cancer are not being met according<br />

to the first ever UK survey into the<br />

experiences of people with pancreatic<br />

cancer. Commissioned by leading<br />

charity Pancreatic Cancer UK, the survey<br />

revealed that half of all respondents<br />

(49 per cent) had one or more unmet<br />

support needs considered either high or<br />

moderate in severity. The findings show<br />

a clear gap in the supportive care being<br />

offered to pancreatic cancer patients –<br />

a group which the charity believes has<br />

been neglected for decades.<br />

The survey, conducted by Oxford Brookes<br />

University and The Picker Institute on behalf<br />

of the charity, recorded the care experiences<br />

and support needs of 274 people with<br />

pancreatic cancer. The majority (87 per<br />

cent) reported one or more support needs,<br />

ranging from depression, fatigue, and<br />

financial pressures, to changes to appetite.<br />

Pancreatic Cancer UK is concerned that<br />

a significant proportion of these needs<br />

are not being met. It is now calling for<br />

the Government and NHS to introduce a<br />

holistic needs assessment to ensure that<br />

patients have access to personalised care<br />

immediately after diagnosis.<br />

One survey respondent said: “I was not<br />

offered counselling though I really felt I<br />

needed it. My physical needs were very well<br />

met but my emotional needs have never<br />

been addressed. I had no idea where to<br />

go for the help I needed and had to search<br />

online for information.”<br />

Patients reported that psychological care<br />

needs were the most likely to be unmet;<br />

almost a third said fears about the future<br />

(31 per cent) or fears about the cancer<br />

spreading (30 per cent) were not being<br />

addressed. This is extremely concerning as<br />

pancreatic cancer has the lowest survival of<br />

all common cancers – less than 7 per cent<br />

of people living for 5 years - and the second<br />

highest risk of suicide after diagnosis<br />

compared to other cancers. This risk of<br />

Currently there are no established<br />

psychological interventions for people<br />

with pancreatic cancer due to a lack<br />

of evidence, and the NICE guidelines<br />

on the disease cite this as a key<br />

area for improvement. The charity is<br />

urging the National Institute for Health<br />

Research (NIHR) to prioritise and invest<br />

research funding for the development of<br />

psychological interventions for people living<br />

with and beyond pancreatic cancer.<br />

Most patients were positive about the<br />

care they received, however, the findings<br />

indicated key differences between the<br />

experiences of people who were eligible to<br />

receive surgery, the only potentially curative<br />

treatment for the disease, and those whose<br />

pancreatic cancer was inoperable. People<br />

with operable pancreatic cancer were<br />

more likely to feel that their diagnosis had<br />

definitely or to some extent been given in<br />

a sensitive way (87 per cent), compared to<br />

inoperable patients (74 per cent). Similarly,<br />

37 per cent of people with inoperable<br />

pancreatic cancer reported that they had<br />

not been given enough information at the<br />

point of diagnosis, compared to 27 per cent<br />

for people with operable disease.<br />

The extent and breadth of needs and the<br />

variations in care experienced by people<br />

with pancreatic cancer has previously<br />

gone unreported because they are not all<br />

captured by the National Cancer Patient<br />

Experience Survey (NCPES). The NCPES<br />

is distributed within six to nine months<br />

of diagnosis when many people with<br />

pancreatic cancer have already died or are<br />

too sick to respond. The low number of<br />

responses mean that pancreatic cancer is<br />

grouped with Upper Gastrointestinal (UGI)<br />

cancers. The NCPES also does not capture<br />

the experience of those living beyond their<br />

diagnosis and treatment.<br />

Anna Jewell, Director of Services at<br />

Pancreatic Cancer UK, said: “For so<br />

many pancreatic cancer patients to tell us<br />

they have unmet support needs is heartbreaking<br />

- these are live needs which if left<br />

patients immediately after diagnosis so that<br />

they can be helped to maintain as good a<br />

quality of life as possible.<br />

No one affected by pancreatic cancer should<br />

be left to struggle in isolation. Specialist<br />

support is available through the Pancreatic<br />

Cancer UK Support Line. Our dedicated<br />

team of nurses are there to help patients<br />

and their families but we need fellow health<br />

professionals to signpost them to us.<br />

The needs of pancreatic cancer patients<br />

have been neglected for far too long. It’s<br />

imperative that these findings now prompt<br />

further research into the most effective<br />

interventions, particularly around mental<br />

health, so that people with pancreatic cancer<br />

receive the very best care and support.”<br />

Amy Tallett, Head of Research at Picker,<br />

commented: “Picker is proud to have<br />

worked with Pancreatic Cancer UK and<br />

Oxford Brookes University on this important<br />

research, and we hope that the findings<br />

provide an essential evidence base to<br />

inform continued conversation and actions<br />

to improve care experiences for people<br />

affected by pancreatic cancer. Thank you to<br />

everybody that took part in this research.”<br />

Eila Watson, Professor Supportive Cancer<br />

Care at Oxford Brookes University,<br />

said: “This survey highlights the unmet<br />

information and support needs that<br />

pancreatic cancer patients have across<br />

the cancer trajectory. Needs should be<br />

assessed from the point of diagnosis and<br />

monitored regularly, with supportive care<br />

interventions implemented to help patients<br />

live as good a quality of life as possible.<br />

Further research is needed to work out how<br />

best to support patients and their families.”<br />

Pancreatic Cancer UK operates the only<br />

dedicated support line for people affected by<br />

pancreatic cancer staffed by specialist nurses.<br />

The Pancreatic Cancer UK Support Line is<br />

free to call on 0808 801 0707 with support<br />

available on weekdays 10am-4pm and via<br />

email: nurse@pancreaticcancer.org.uk<br />

24


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At home they<br />

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reduces the risk<br />

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Long-term secondary prophylaxis in hepatic<br />

encephalopathy (HE) 3<br />

UK&IE Prescribing Information: Targaxan 550mg (rifaximin-α)<br />

REFER TO FULL SUMMARY OF PRODUCT CHARACTERISTICS (SmPC)<br />

BEFORE PRESCRIBING<br />

Presentation: Film-coated tablet containing rifaximin 550 mg.<br />

Uses: Targaxan is indicated for the reduction in recurrence of episodes<br />

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Dosage and administration: Adults 18 years of age and over: 550 mg<br />

twice daily, with a glass of water, with or without food for up to 6 months.<br />

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including those associated with the progression of the patients hepatic<br />

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Contraindications: Contraindicated in hypersensitivity to rifaximin,<br />

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intestinal obstruction.<br />

Warnings and precautions for use: The potential association of<br />

rifaximin treatment with Clostridium difficile associated diarrhoea and<br />

pseudomembranous colitis cannot be ruled out. The administration<br />

of rifaximin with other rifamycins is not recommended. Rifaximin<br />

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in patients with severe (Child-Pugh C) hepatic impairment and in<br />

patients with MELD (Model for End-Stage Liver Disease) score > 25.<br />

In hepatic impaired patients, rifaximin may decrease the exposure of<br />

concomitantly administered CYP3A4 substrates (e.g. warfarin,<br />

antiepileptics, antiarrhythmics, oral contraceptives). Both decreases and<br />

increases in international normalized ratio (in some cases with bleeding<br />

events) have been reported in patients maintained on warfarin and<br />

prescribed rifaximin. If co-administration is necessary, the international<br />

normalized ratio should be carefully monitored with the addition or<br />

withdrawal of treatment with rifaximin. Adjustments in the dose of<br />

oral anticoagulants may be necessary to maintain the desired level of<br />

anticoagulation. Ciclosporin may increase the rifaximin Cmax<br />

Pregnancy and lactation: Rifaximin is not recommended during<br />

pregnancy. The benefits of rifaximin treatment should be assessed<br />

against the need to continue breastfeeding.<br />

Side effects: Common effects reported in clinical trials are dizziness,<br />

headache, depression, dyspnoea, upper abdominal pain, abdominal<br />

distension, diarrhoea, nausea, vomiting, ascites, rashes, pruritus, muscle<br />

spasms, arthralgia and peripheral oedema. Other effects that have<br />

been reported include: Clostridial infections, urinary tract infections,<br />

candidiasis, pneumonia cellulitis, upper respiratory tract infection and<br />

rhinitis. Blood disorders (e.g. anaemia, thrombocytopenia). Anaphylactic<br />

reactions, angioedemas, hypersensitivity. Anorexia, hyperkalaemia and<br />

dehydration. Confusion, sleep disorders, balance disorders, convulsions,<br />

hypoesthesia, memory impairment and attention disorders.<br />

Hypotension, hypertension and fainting. Hot flushes. Breathing difficulty,<br />

pleural effusion, COPD. Gastrointestinal disorders and skin reactions.<br />

Liver function test abnormalities. Dysuria, pollakiuria and proteinuria.<br />

Oedema. Pyrexia. INR abnormalities. Prescribers should consult the<br />

SmPC in relation to all adverse reactions.<br />

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Legal category: Prescription only<br />

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Telephone: 01895 826 606<br />

E-mail: Medinfo@norgine.com<br />

Ref: UK/XIF5/0119/0477<br />

Date of preparation: January <strong>2019</strong><br />

United Kingdom<br />

Adverse events should be reported. Reporting forms and<br />

information can be found at www.mhra.gov.uk/yellowcard.<br />

Adverse events should also be reported to Medical<br />

Information at Norgine Pharmaceuticals Ltd on:<br />

Tel. +44 (0)1895 826 606<br />

Email Medinfo@norgine.com<br />

Ireland<br />

Healthcare professionals are asked to report any<br />

suspected adverse reactions via HPRA Pharmacovigilance,<br />

Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;<br />

Fax: +353 1 6762517. Website: www.hpra.ie;<br />

E-mail: medsafety@hpra.ie. Adverse events should<br />

also be reported to Medical Information at<br />

Norgine Pharmaceuticals Ltd on: Tel. +44 (0)1895 826 606<br />

Email Medinfo@norgine.com<br />

References:<br />

1. National Institute for Health and Care Excellence.<br />

Rifaximin for preventing episodes of overt hepatic encephalopathy:<br />

appraisal guidance TA337 for rifaximin.<br />

Available from: http://www.nice.org.uk/guidance/ta337<br />

2. TARGAXAN ® 550 Summary of Product Characteristics.<br />

Available for the UK from: https://www.medicines.org.uk/emc<br />

Available for Ireland from: www.medicines.ie<br />

3. Mullen KD, et al. Clin Gastroenterol Hepatol<br />

2014;12(8):1390-97.<br />

Product under licence from Alfasigma S.p.A. TARGAXAN is a<br />

registered trademark of the Alfasigma group of companies, licensed<br />

to the Norgine group of companies. NORGINE and the sail logo are<br />

registered trademarks of the Norgine group of companies.<br />

UK/XIF5/0219/0487<br />

Date of preparation: February <strong>2019</strong>.<br />

GASTROENTEROLOGY TODAY - SUMMER <strong>2019</strong><br />

25


COMPANY NEWS<br />

THE INFECTION RISK IS REAL<br />

In 2010, Cantel (UK) Ltd became the first company to offer<br />

sterile single-use endoscope valves and in 2018 became the first<br />

supplier in the UK to provide sterile single-use valves compatible<br />

with GI endoscopes from Olympus, Pentax and Fujifilm.<br />

Reducing the risk of infections for endoscopy patients is critically<br />

important. More Healthcare Associated Infections (HAIs) and outbreaks<br />

have been linked to contaminated endoscopes than to any other<br />

medical device. 1 For patients who contract HAIs the consequences<br />

can be significant. In the UK, HAIs are estimated to cost the NHS<br />

approximately £1 billion a year. 2<br />

The risk of infection from improperly cleaned and disinfected reusable<br />

endoscope valves is extremely high due to their complex design. A<br />

laboratory study of “patient-ready” valves found 56% were contaminated<br />

with bacteria, yeast, moulds and bacterial spores. 3 Meticulous brushing<br />

is required during reprocessing and that still may not be sufficient to<br />

ensure a safe, patient-ready endoscope. DEFENDO Sterile Singleuse<br />

Valves solve the issue of reusable valve reprocessing by offering a<br />

single-use option which ensures sterile valves for every procedure.<br />

DEFENDO Valves are high-performance, high-quality products that<br />

support procedural control and efficiency. Cantel’s verification testing<br />

includes multiple tests for force and suction to help create valves that<br />

don’t exhibit some of the common issues with reusable and other<br />

single-use valves: clogging, sticking and loss of insufflation. When you<br />

experience these issues during a procedure, the result can be a longer,<br />

more difficult procedure.<br />

With every guideline update, there is clear direction that singleuse<br />

accessories are highly recommended. The British Society of<br />

<strong>Gastroenterology</strong> guidance states “’Single-use’ accessories should<br />

always be used” 4 and the recently updated ESGENA guidelines state<br />

that “endoscope valves can also show contamination after reprocessing<br />

and may be the source of infections if cleaning, drying, storage, and<br />

hand hygiene are inadequate. There is an increasing trend for using<br />

detachable endoscope components as single-use products to enable<br />

full traceability and to prevent cross-infection caused by inadequately<br />

reprocessed detachable components such as valves and distal caps”. 5<br />

DEFENDO Valves provide the most advanced protection for your<br />

patients by helping to create consistent practices and reducing the risk<br />

of potential errors. Single-use valves are supplied by Cantel (UK) Ltd<br />

in a number of convenient kits which include: Air/ Water, Suction and<br />

Biopsy Valves, as well as a Single Use Auxiliary Water Jet Connector.<br />

Contact Cantel on 01702 291878 to arrange a free demonstration of<br />

DEFENDO Sterile Single-Use Valves.<br />

www.cantelmedical.co.uk<br />

References<br />

1. Rutala, W.A., Weber, D. J., and the Healthcare Infection Control<br />

Practices Advisory Committee (2008). Guideline for Disinfection<br />

and Sterilization in Healthcare Facilities (Last update: February 15,<br />

2017). Retrieved from CDC: https://www.cdc.gov/ infectioncontrol/<br />

pdf/guidelines/disinfection-guidelines.pdf<br />

2. National costing statement: Infection prevention and control (2012,<br />

March)<br />

3. Pearce, P.J. (2011, August). A Report on the Widespread<br />

Inadequate Reprocessing of Endoscope Air/Water and Suction<br />

Valves by Healthcare Facilities. Retrieved from: http://www.<br />

medivators.com/sites/default/files/minntech/documents/<br />

Improper%20Valve%20Reprocessing%20Study_Sept%20<br />

2017_50098-1504%20Rev%20A.pdf<br />

4. BSG. “Guidance for Decontamination of Equipment for<br />

Gastrointestinal Endoscopy.” (2016, November)<br />

5. Reprocessing of flexible endoscopes and endoscopic accessories<br />

used in gastrointestinal endoscopy: Position Statement of the<br />

European Society of Gastrointestinal Endoscopy (ESGE) and<br />

European Society of <strong>Gastroenterology</strong> Nurses and Associates<br />

(ESGENA) – Update 2018<br />

GASTROENTEROLOGY TODAY - SUMMER <strong>2019</strong><br />

26


COMPANY NEWS<br />

GASTROENTEROLOGY TODAY - SUMMER <strong>2019</strong><br />

27


COMPANY NEWS<br />

IMPORTANT NEW TRIAL WITH ORAL FERACCRU ® SHOWS COMPARABLE<br />

EFFICACY TO IV IRON (FERRIC CARBOXYMALTOSE), OFFERING A REAL<br />

ALTERNATIVE TO HOSPITAL ADMINISTRATION FOR MANY PATIENTS [4]<br />

• FERACCRU ® (Ferric Maltol) met primary endpoint against Ferinject ® (IV<br />

Ferric Carboxymaltose (FCM)) and shows clear benefits to Iron Deficiency<br />

Anaemia (IDA) patients with inactive Inflammatory Bowel Disease (IBD) 4<br />

• FERACCRU ® delivered a haemoglobin (Hb) response rate at 12 weeks that<br />

was within 9% of the effect seen with a market leading IV iron treatment<br />

(IVI FCM), but without the need for hospital-based administration 4<br />

• FERACCRU ® was efficiently absorbed and well tolerated over the extended<br />

treatment period, in line with previous studies 2<br />

Shield Therapeutics plc (Shield) and Norgine B.V. (Norgine) have<br />

announced positive results from the AEGIS Head-to-Head (H2H) clinical<br />

trial, which compared FERACCRU ® (ferric maltol), a novel oral iron<br />

replacement therapy, to Ferinject ® (ferric carboxymaltose (FCM)), a<br />

market-leading intravenously delivered iron replacement therapy 4 .<br />

In the AEGIS-H2H study, ferric maltol demonstrated increases in the mean<br />

Hb levels that were comparable to IV FCM. Patients with Iron Deficiency<br />

Anaemia (IDA), whose Inflammatory Bowel Disease (IBD) is inactive now<br />

have an important alternative treatment option, which is both effective<br />

over the long term and well tolerated, therefore reducing the need for<br />

time-consuming and expensive hospital administration. Current oral iron<br />

treatments can be poorly tolerated and don’t always work 7 , which leads to<br />

many unwell patients having to receive IV iron in hospital.<br />

“The results of this study provide an important opportunity to change<br />

clinical practice to improve patients’ lives. Patients with inactive<br />

Inflammatory Bowel Disease who are unwell as a result of Iron Deficiency<br />

Anaemia have often tried a number of oral iron treatments which didn’t<br />

work or they couldn’t tolerate,” commented Dr Alastair Benbow, Chief<br />

Medical and Development Officer at Norgine. “Previously, they would<br />

have needed to go to hospital for time-consuming and expensive IV<br />

administration. Now many patients can be treated at home with an<br />

effective and well-tolerated oral iron alternative,” he added.<br />

More detailed analyses of the data, including the secondary endpoints<br />

and safety parameters, will be presented at Shield’s upcoming<br />

presentation of its preliminary results for 2018, scheduled for early<br />

April <strong>2019</strong>, whilst the full data will be submitted for peer-review and<br />

subsequent presentation by the study’s lead investigators at upcoming<br />

scientific meetings.<br />

FERACCRU ® is a novel, effective and well tolerated treatment, which<br />

is approved and marketed in the European Union for the treatment of<br />

iron deficiency (ID) in adults and in Switzerland for the treatment of iron<br />

deficiency anaemia (IDA) in adults with inflammatory bowel disease<br />

(IBD) 1-3 . A New Drug Application in the USA is being reviewed by the<br />

FDA with a PDUFA date of 27 July <strong>2019</strong>.<br />

On 19 September 2018, Norgine entered into an exclusive licence<br />

agreement with Shield Therapeutics plc for the commercialisation of the<br />

product in Europe, Australia and New Zealand.<br />

WHY NOT WRITE FOR US?<br />

GASTROENTEROLOGY TODAY - SUMMER <strong>2019</strong><br />

<strong>Gastroenterology</strong> <strong>Today</strong> welcomes the submission of<br />

clinical papers and case reports or news that<br />

you feel will be of interest to your colleagues.<br />

Material submitted will be seen by those working within all<br />

UK gastroenterology departments and endoscopy units.<br />

All submissions should be forwarded to info@mediapublishingcompany.com<br />

If you have any queries please contact the publisher Terry Gardner via:<br />

info@mediapublishingcompany.com<br />

28


COMPANY NEWS<br />

GASTROENTEROLOGY TODAY - SUMMER <strong>2019</strong><br />

29


COMPANY NEWS<br />

NORGINE NEW STUDY HIGHLIGHTS NEED TO<br />

INCREASE PUBLIC UNDERSTANDING OF IMPORTANT<br />

ROLE OF COLONOSCOPY IN PREVENTING AND<br />

DIAGNOSING GASTROINTESTINAL DISEASES,<br />

INCLUDING COLORECTAL CANCER<br />

GASTROENTEROLOGY TODAY - SUMMER <strong>2019</strong><br />

30<br />

• Those with no previous experience of colonoscopy were<br />

considerably more nervous about the procedure than those<br />

who had already undergone colonoscopy (74% vs 49%)<br />

• Current lack of public understanding around colonoscopy<br />

may be negatively impacting on number of eligible people<br />

attending their colonoscopy appointment<br />

• Less than half (45%) of those who had not had the<br />

procedure knew that a colonoscopy could prevent colorectal<br />

cancer<br />

AMSTERDAM, April 4, <strong>2019</strong> /PRNewswire/ -- NORGINE B.V. (Norgine)<br />

today published the findings of a public survey at the European Society<br />

of Gastrointestinal Endoscopy (ESGE) Days in Prague as we celebrate<br />

the 50th anniversary of the first colonoscopy. [1],[2],[3] This important study<br />

highlights the need to increase public understanding of the important<br />

role of colonoscopy in the prevention and diagnosis of gastrointestinal<br />

diseases including colorectal cancer. The survey was conducted across<br />

five major European countries and included both people who had<br />

undergone a colonoscopy and those who have no previous experience<br />

with the procedure.<br />

The study findings highlighted the misconceptions and strong negative<br />

associations about colonoscopy amongst those who have had no<br />

previous experience with the procedure. Those with no previous<br />

experience of colonoscopy were considerably more nervous about the<br />

procedure than those who had already undergone colonoscopy (74% vs<br />

49%). This may be one of the reasons why many eligible people do not<br />

attend their colonoscopy appointments each year [4] - a vital procedure<br />

for the prevention and diagnosis of gastrointestinal diseases, including<br />

colorectal cancer. The target population for colorectal cancer screening<br />

in the EU is close to 69,000,000, but only 14% of the target population is<br />

currently being screened. [4]<br />

This study has highlighted the benefit of public education to increase<br />

understanding of the importance of the colonoscopy procedure, and<br />

particularly its important role in preventing colorectal cancer. Less<br />

than half (45%) of those who had not had the procedure knew that a<br />

colonoscopy could prevent colorectal cancer. Other findings suggested<br />

the need to improve patient experience of the procedure, including<br />

bowel preparation and the provision of relevant information. This may<br />

provide an opportunity for healthcare professionals to further support<br />

their patients.<br />

“This survey highlights the lack of information about colonoscopy in<br />

public domain. Clinicians need to provide easily accessible and clear<br />

information about colonoscopy to improve the uptake of bowel cancer<br />

screening program in our fight against colorectal cancer,” said Professor<br />

Pradeep Bhandari, Consultant Gastroenterologist, QA Hospital,<br />

Portsmouth.<br />

In the 50 years since the first colonoscopy, the procedure has become a<br />

crucial tool in the prevention and detection of gastrointestinal disorders,<br />

including colorectal cancer. Despite significant advances, however, the<br />

variation in uptake across Europe continues to prevent the potential of<br />

colonoscopy being fully realised for patients and health systems.<br />

The survey asked 500 and 2500 people with and without colonoscopy<br />

experience across five main EU countries (UK, Germany, France, Spain<br />

and Italy) about their experience and understanding of colonoscopy.<br />

[1],[2],[3]<br />

Follow us @norgine<br />

www.norgine.com<br />

References<br />

[1] Bhandari P, Amlani B, Radaelli F. ePP31 Public attitudes to<br />

colonoscopy: The purpose of colonoscopy. Presented at ESGE<br />

<strong>2019</strong>, Prague. https://www.professionalabstracts.com/esge<strong>2019</strong>/<br />

iplanner/#/presentation/336 Last accessed April <strong>2019</strong><br />

[2] Amlani B, Bhandari P, Radaelli F. ePP92 Public attitudes to<br />

colonoscopy: Experience of colonoscopy. Presented at ESGE<br />

<strong>2019</strong>, Prague. https://www.professionalabstracts.com/esge<strong>2019</strong>/<br />

iplanner/#/presentation/409 Last accessed April <strong>2019</strong><br />

[3] Bhandari P, Amlani B, Radaelli F. OP362 Public attitudes to<br />

colonoscopy: Embarrassment levels and colonoscopy. Presented<br />

at ESGE <strong>2019</strong>, Prague. https://www.professionalabstracts.com/<br />

esge<strong>2019</strong>/iplanner/#/presentation/890 Last accessed April <strong>2019</strong><br />

[4] European Commission, Cancer Screening in the European Union,<br />

Report on the implementation of the Council recommendation on<br />

cancer screening, 2017. https://ec.europa.eu/health/sites/health/<br />

files/major_chronic_diseases/docs/2017_cancerscreening_2ndrepo<br />

rtimplementation_en.pdf Last accessed April <strong>2019</strong>


COMPANY NEWS<br />

driving scientific advancements in digestive health<br />

October 19-23, <strong>2019</strong><br />

Venue: Fira Gran Via, Barcelona<br />

Ahead of UEG Week Barcelona <strong>2019</strong>, UEG<br />

President Professor Paul Fockens discusses<br />

why he is looking forward to one of the<br />

world’s premier digestive health meetings.ngs.<br />

UEG Week is the largest<br />

and most prestigious<br />

gastroenterology meeting<br />

of its kind, with more than 14,000<br />

delegates from over 110 countries<br />

worldwide.<br />

The UEG Scientific Committee is<br />

developing a state-of-the-art<br />

scientific programme, featuring the<br />

latest advancements and most exciting<br />

research in digestive health.<br />

This will ensure the delivery of<br />

world-class presentations across a<br />

range of specialties, covering clinical,<br />

translational and basic science. An<br />

inclusive offering is provided for all<br />

attendees, whatever their level of<br />

expertise, featuring a broad variety<br />

of sessions that include symposia,<br />

live endoscopy and abstract-based<br />

sessions. Different interactive formats<br />

allow lively interaction between the<br />

audience, chairs and speakers.<br />

The two-day Postgraduate Teaching<br />

Programme will provide profound<br />

updates on a wide range of<br />

gastrointestinal and hepatology topics<br />

that suit both gastroenterologists<br />

in training as well as established<br />

physicians and general practitioners.<br />

The programme focuses on the<br />

relevance for the clinical day-to-day<br />

business and enables participants<br />

to get perfectly prepared for their<br />

professional career. <strong>2019</strong> marks year 3<br />

of our rolling 3-year curriculum.<br />

UEG Week will once again host the<br />

hugely successful ‘<strong>Today</strong>’s Science,<br />

Tomorrow’s Medicine’ initiative and<br />

this year’s theme will be ‘Microbiota:<br />

Moving towards clinics’. Here, topclass<br />

scientists will be invited to<br />

discuss how current knowledge and<br />

thinking is ready to be used in clinical<br />

practice and establish strategies to<br />

foster further progression in this area.<br />

UEG Week provides an exceptional<br />

opportunity for investigators from<br />

around the globe to submit and<br />

present their latest findings. UEG will<br />

present a number of awards at the<br />

congress, including the Top Abstract<br />

Prizes, the UEG Research Prize and the<br />

UEG Rising Star Awards.<br />

I am anticipating a very exciting<br />

week of scientific advances and<br />

updates from leading digestive health<br />

experts and thoroughly look forward<br />

to welcoming new and returning<br />

delegates to UEG Week Barcelona<br />

<strong>2019</strong>.<br />

To find out more,<br />

visit: ueg.eu/week<br />

Benefit from<br />

reduced delegate<br />

fees until<br />

September 5,<br />

<strong>2019</strong><br />

Late-breaking<br />

abstract<br />

submission<br />

opens August<br />

19, <strong>2019</strong><br />

GASTROENTEROLOGY TODAY - SUMMER <strong>2019</strong><br />

31


COMPANY NEWS<br />

NEW CHIEF EXECUTIVE OFFICER ANNOUNCEMENT<br />

Coeliac UK, the national charity for people who need to live<br />

gluten free, has appointed Hilary Croft as its new CEO from<br />

3 June <strong>2019</strong>, succeeding Sarah Sleet.<br />

Ms Croft’s professional background lies in business transformation<br />

within complex, multifaceted organisations. Her senior management<br />

career started in marketing with Capgemini, a global leader in consulting,<br />

technology and digital transformation services, where she worked with a<br />

variety of organisations, such as Virgin Atlantic, Sky, Lego and Royal Mail.<br />

Hilary Croft also has vast knowledge and interest in the food and drink<br />

sector through previous positions with Marks and Spencer, Coca-Cola,<br />

Compass Group and World Duty Free Europe. More recently, as CEO<br />

of the Felix Project, she developed significant partnerships with food<br />

suppliers and re-distributers to reduce food waste and food poverty<br />

across London.<br />

About her appointment, Ms Croft said: “I am excited to be taking<br />

up the CEO role at Coeliac UK, a charity with a truly unique health<br />

and food scope. I look forward to developing the charity’s strong<br />

reputation, bringing fresh ideas and strategic insights. Naturally, my<br />

direct experience of coeliac disease, through my son’s condition, further<br />

motivates me to achieve real and lasting change for the gluten free<br />

community.”<br />

Mike Elliott, Coeliac UK’s Chair of Governors, said: “Hilary’s business<br />

and strategic acumen will bring new drive and impetus at this exciting<br />

time in Coeliac UK’s journey. The charity is currently entering a new ten<br />

year strategic review and requires an experienced change leader to<br />

adapt to a constantly evolving, complex environment. We feel Hilary is<br />

exceptionally qualified to lead Coeliac UK into the future and we look<br />

forward to welcoming her.”<br />

Ms Croft is also a trustee of Age UK Ealing and a global fundraising<br />

committee member for Tearfund, a charity that helps communities<br />

around the world escape the very worst effects of poverty and disaster.<br />

About Coeliac UK<br />

Coeliac UK campaigns for better access to diagnosis of coeliac disease<br />

and funds critical research into potential cures. It provides expert and<br />

independent information to 65,000 members to manage their health and<br />

gluten free diet.<br />

The charity also fights for wider availability of gluten free food by working<br />

with food manufacturers, service providers and venues. Currently 3,000<br />

products and 200 companies use the charity’s Crossed Grain certification<br />

scheme and 3,200 food outlets, cafés and restaurants have achieved its<br />

Gluten Free accreditation. In 2018, the charity’s total income was £4.1m<br />

with research expenditure increasing from £204k to £496k.<br />

WHY NOT WRITE FOR US?<br />

<strong>Gastroenterology</strong> <strong>Today</strong> welcomes the submission of<br />

clinical papers and case reports or news that<br />

you feel will be of interest to your colleagues.<br />

GASTROENTEROLOGY TODAY - SUMMER <strong>2019</strong><br />

Material submitted will be seen by those working within all<br />

UK gastroenterology departments and endoscopy units.<br />

All submissions should be forwarded to info@mediapublishingcompany.com<br />

If you have any queries please contact the publisher Terry Gardner via:<br />

info@mediapublishingcompany.com<br />

32


COMPANY NEWS<br />

THE GUT HEALTH EXPERTS<br />

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digestive<br />

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GASTROENTEROLOGY TODAY - SUMMER <strong>2019</strong><br />

*based on Euromonitor brand sales<br />

www.bioglan.co.uk<br />

33


COMPANY NEWS<br />

NORGINE: NEW REAL WORLD STUDY SHOWS<br />

RIFAXIMIN-A SIGNIFICANTLY REDUCED<br />

HOSPITALISATION IN PATIENTS WITH OVERT HEPATIC<br />

ENCEPHALOPATHY (HE) WHEN ADDED TO LACTULOSE<br />

• Rifaximin-a in combination with lactulose, the standard of<br />

care (SOC) treatment resulted in significant reductions<br />

(p


COMPANY NEWS<br />

GASTROENTEROLOGY TODAY - SUMMER <strong>2019</strong><br />

35


Helicobacter Test INFAI ®<br />

The most used 13 C-urea breath test for the<br />

diagnosis of Hp-infection worldwide<br />

• more than 4.5 million INFAI tests performed in Europe<br />

• approved for children from the ages of 3 to 11<br />

• special INFAI test for patients with dyspepsia taking PPIs<br />

• cost-effective CliniPac Basic version for hospital use<br />

INFAI Institute for Biomedical Analysis & NMR Imaging, INFAI UK Ltd<br />

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Phone +44 1904 435 228 - Fax +44 1904 435 229 - mail: info@infai.co.uk - Visit us at www.infai.com

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