Small Bowel Tumors - International Conference on Capsule ...

Inflammatory <strong>Bowel</strong> Disease (IBD)
Page 2: Capsule Endoscopy (CE) as a first-line tool for
Crohn’s disease of the small bowel
Clinical Practice
Page 3: Broad range of topics presented on latest
developments in CE and clinical practice
<strong>Small</strong> <strong>Bowel</strong> <strong>Tumors</strong>
Page 4: Prevalence of small bowel tumors considerably
higher than previously believed
GI Bleeding
Page 5: Diagnostic equivalence of CE and intraoperative
enteroscopy, OGIB and IDA findings
Outcomes & Patient Management
Page 6: Significant data on positive health-economic
outcomes after CE
Emerging Indications & Applications
Page 7: Celiac disease, new technologies for
evaluating the esophagus and strictures
3 rd Annual ICCE Consensus
Page 8: Results of annual voting by ICCE delegates on
key issues for CE within clinical practice
Mark Your Calendar
for ICCE 2005
The next <strong>International</strong> <strong>Conference</strong>
on Capsule Endoscopy will be
March 7 – March 9, 2005.
E-mail icce@givenimaging.com to
receive future updates on the
conference.
This year’s annual <strong>International</strong> <strong>Conference</strong> on Capsule Endoscopy
(ICCE) was held this spring in Miami, Florida, USA. Spanning several
days, the ICCE is the only in-depth international congress focusing
entirely on Capsule Endoscopy (CE). ICCE 2004 was led by co-chairs
David R. Cave, MD, PhD, St. Elizabeth's Medical Center, Boston,
Massachusetts and David Fleischer, MD, Mayo Clinic, Scottsdale,
Arizona, USA. Together with the conference committee, Drs. Cave and
Fleischer organized the diverse and highly-focused scientific program.
The ICCE <strong>Conference</strong> Report is a summary of selected presentations
organized by key topics.
With over 90 presentations, ICCE 2004 was marked by nearly double
last year’s attendance—over 300 participants from 30 countries. This
reflects the growing impact of CE on the field of gastroenterology: since
M2A ® Capsule Endoscopy was introduced in May 2001, more than
1,800 systems are in use worldwide and more than 100,000 M2A
Capsules have been ingested. Clinical data covering thousands of
patients presented at major conferences is resulting in expanded
indications for CE as well as revised local reimbursement policies.
Working groups met to propose solutions and share clinical experience
on topics such as prep and prokinetics, optimizing Localization and
Suspected Blood Indicator (SBI) features, and managing patients with
capsule retention. The ICCE Learning Lab provided the opportunity to
review CE case studies; delegates with challenging cases were able to
get feedback on their videos and suggestions for case management from
leading practitioners.
A major goal of the annual ICCE is to form a consensus on various
important issues regarding the use of Capsule Endoscopy within clinical
practice. An interactive electronic survey tool polled the conference
attendees and tabulated the consensus results. These results, called the
3rd Annual ICCE Consensus, are summarized on p. 8.
The entire 3 rd <strong>International</strong> <strong>Conference</strong> on Capsule Endoscopy Program & Abstracts
book can be downloaded from Healthcare Professionals at www.givenimaging.com.

ICCE 2004 MIAMI CONFERENCE REPORT
Inflammatory <strong>Bowel</strong> Disease (IBD)
At ICCE 2004, presentations on IBD focused primarily on
M2A Capsule Endoscopy for Crohn’s disease of the small
intestine. Presentations of studies by J. A. Leighton et al (USA),
E. Toth et al (Sweden), A. L. Buchman et al (USA), W. Landry
et al (Germany) and M. H. Dirks et al (Canada) emphasized the
clinical efficacy and high diagnostic yield of CE for Crohn’s
disease. It was noted that diagnosis and adequate therapy are
frequently delayed due to limitations of other diagnostic
modalities, particularly for early stages of Crohn’s disease and
elusive small bowel lesions that were previously difficult to
view directly. In addition to small bowel Crohn’s disease, M.
Appleyard et al (Australia) also presented data on Capsule
Endoscopy for IBD in other parts of the GI tract.
Since the last ICCE, significant clinical data published in GI
peer-reviewed journals1 have resulted in expanded
reimbursement in many countries and a global increase in usage
of CE for suspected Crohn’s disease in adult as well as pediatric
patients. Discussion among participants at ICCE 2004 on and
off the conference floor reflected these trends—especially the
paradigm shift in clinical practice: Capsule Endoscopy is
STATE-OF-THE-ART
Stefan Schreiber, University of Kiel
Hospital, Kiel, Germany
In a comprehensive presentation, S. Schreiber
covered the available diagnostic modalities and
therapies for Crohn’s disease. The important
role of Capsule Endoscopy for Crohn’s disease
was outlined, with localization and extent of
the disease cited as 25% colitis, 5%
gastroduodenitis, 30% ileitis/jejunoileitis and
40% ileocolitis. Visualization via M2A Capsule
Endoscopy of inflammatory processes in the
small intestine (right) was described in detail.
Early data and M2A images from the new
multi-center, multi-national study on using CE
for monitoring clinical remission in Crohn’s
disease patients were also presented.
S. Schreiber is Principal Investigator of this
long-term, multi-center study which is
expected to continue for 18-24 months and
involves 9 countries worldwide. In this
ongoing study, Capsule Endoscopy is used to
visualize lesions in diagnosed Crohn’s disease
patients that may be predictive for future
relapses and to determine whether the relapse
originates from these same lesions. The intent
is to use these lesions in the future as a marker
to better direct an intensified remission
maintenance therapy.
* The M2A Patency System is not yet available in the
USA; it received the CE Mark and is currently being
marketed in Europe, Australia and other countries.
M2A ® Images
Visualization of Inflammatory Processes
in the <strong>Small</strong> Intestine
Villous erosion
emerging as a first-line tool for diagnosing as well as for
monitoring Crohn’s disease2 .
According to S. Schreiber (Germany) and colleagues, the M2A
Patency SystemTM * (see p. 7) can be included in this paradigm
to assure patency prior to M2A Capsule Endoscopy for patients
with suspected or known stenoses and fistulae, which often
complicate Crohn’s disease. Ongoing clinical work presented
by P. E. Legnani et al (USA) on the Crohn’s Disease Capsule
Endoscopic Scoring Index aims to standardize terminology
characterizing the extent and severity of lesions in Crohn’s
disease visualized by CE.
In his keynote speech, J. Barkin described known diseases of
the GI tract, such as Crohn’s disease, as “the tip of the iceberg”
and how with CE, GI specialists are now diagnosing Crohn’s
disease patients who were symptomatic, but previously not
diagnosed. He also said that for Crohn’s disease “we are going
to find [with CE] that there is a whole group of patients who are
asymptomatic, have early disease and represent a population
that we can treat and maybe change the natural course of their
disease—an exciting breakthrough.”
Thickened infiltrated folds
(jejunum)
Aphthous ulcerations (ileum) Linear ulcerations
Courtesy of Stefan Schreiber, University of Kiel Hospital, Kiel, Germany
2

Clinical Practice
This ICCE 2004 featured a broad range of
topics on Capsule Endoscopy and clinical
practice. Presentations on CE and
pediatrics * by E. Seidman et al (Canada), J.
Romero et al (Spain); D. Bai et al (USA), H.
Nuutinen et al (Finland) M. Lapalus et al
(France), B. Barth et al (USA) and M. H.
Dirks et al (Canada) evaluated children
together with adults as part of their studies.
Several presentations also covered
endoscopic placement for certain patients,
such as in young patients as reported by H.
Nuutinen et al (Finland).
Conclusions from the initial study presented
at last year’s ICCE on CE and pacemakers
by S.F. Diez (Spain) Cardiac Pacemaker: A
Real Contraindication ** for Capsule
Endoscopy? 3 were reinforced by the ICCE
2004 consensus voting, as well as the studies
by J. Perez Piqueras et al (Spain) and J. A.
Leighton et al (USA).
ICCE 2004 MIAMI CONFERENCE REPORT
Managing capsule retention [a.k.a. nonnatural
excretion (NNE)], is now considered
an aspect (albeit uncommon) of CE clinical
practice which can actually aid diagnosis; this
topic was the specific focus of studies by B. S.
Lewis et al (USA), J. A. Leighton et al (USA),
R. Sachdev et al (USA), A. S. Cheifetz et al
(USA) as well as the working group led by J.
S. Barkin (USA) and M. Pennazio (Italy).
Progress reports were presented on
international standardization efforts such as
defining a Capsule Endoscopy Minimum
Standard Terminology (CE-MST) by B. S.
Lewis, and a Crohn’s Disease CE Scoring
Index by P. E. Legnani et al (USA).
According to session moderators M. Delvaux
(France), L. Y. Korman (USA) and B. S.
Lewis (USA), these ongoing efforts reflect the
increasing need, as CE usage grows, for
common language among GI professionals
for characterizing M2A Capsule Endoscopy
findings.
UTILITY OF CAPSULE ENDOSCOPY IN PEDIATRIC PATIENTS WITH
SUSPICION OF SMALL BOWEL DISORDERS (PRELIMINARY REPORT)
Javier Romero, Virgen Macarena University Hospital, Seville, Spain
This presentation by J. Romero evaluated the effectiveness and safety of CE in pediatric patients
(ages 8-16 years old) with suspected small bowel disorders. The primary indication was “a clinical
and analytical suspicion of Crohn’s disease (CD) not confirmed with traditional methods
(gastroscopy, colonoscopy and small bowel follow-through).” CE identified lesions suggestive of
Crohn’s disease (aphthous, fissures, ulcers) in 77.78% of the patients with this indication. Romero
concluded that CE appears to be safe in children over 8 years old.
SAFETY OF WIRELESS CAPSULE ENDOSCOPY (CE) IN PATIENTS WITH
PACEMAKERS
Jonathan A. Leighton, Mayo Clinic, Scottsdale, Arizona, USA
Study published in the April 2004 issue of Gastrointestinal Endoscopy 4
In his presentation, J. A. Leighton described the significance of the patient population studied:
“Many patients with GI disorders, especially GI bleeding of obscure origin (OGIB) are elderly, and
some have underlying cardiac disease that requires pacemaker implantation. Therefore, it is of
critical importance to know whether CE can be used safely in this group of patients.” J. A. Leighton
concluded: CE appears to be safe in patients with cardiac pacemakers and does not appear to be
associated with any significant adverse events. Pacemakers do not interfere with CE imaging.
Larger studies, however, will be required to confirm these observations and to formulate guidelines
for the use of CE in patients with pacemakers. Capsule Endoscopy in patients with an implantable
cardioverter defibrillator (ICD) was not evaluated by the present study. Further study is needed of
the safety of CE in patients with an ICD. As a result of this study, the Mayo Clinic in Scottsdale
no longer withholds Capsule Endoscopy from patients with pacemakers, but this subpopulation is
continuing to be followed prospectively. In addition, patients with pacemakers are no longer
routinely hospitalized.
* In the USA, Capsule Endoscopy is cleared for use in patients from age 10.
** There is a theoretical potential for interference between the digital radiofrequency communication of the M2A Capsule
(434.09 MHz) and a cardiac pacemaker. This concern led the US Food and Drug Administration and the manufacturer
(Given Imaging Ltd.) to list the presence of a cardiac pacemaker as a relative contraindication to the use of CE.
3
M2A ® Images
Crohn’s Disease
in Pediatric
Patients
Aphthous, ulcerative lesion
in ileum of pediatric patient
Courtesy of Javier Romero,
Virgen Macarena University
Hospital, Seville, Spain
Multiple jejunal and ileal
ulcers, occasional
inflammatory stricture
Courtesy of Ernest Seidman,
Sainte Justine Hospital,
Montreal, Canada

<strong>Small</strong> <strong>Bowel</strong> <strong>Tumors</strong>
Clinical findings at ICCE 2004 from four
presentations: B. S. Lewis et al (USA),
M. Keuchel et al (Germany), M. Delvaux
for G. Gay et al (France) and E. Toth et al
(Sweden) covering CE data for 1042
patients showed 6–8.9% diagnosed
with small bowel tumors (SBT)—
indicating that the prevalence of small
bowel tumors is considerably higher than
previously believed. Researchers
attributed this to the direct visualization
of the entire small bowel and increased
diagnostic yield of CE; they
also discussed delays in diagnosis
due to difficulty visualizing the small
intestine with other methods.
ICCE 2004 MIAMI CONFERENCE REPORT
Over half of the tumors diagnosed via
CE were malignant, including tumors in
the ileum and jejunum not visualized by
any other modality.
Presentations of Grand Rounds video
forum cases by R. de Franchis et al
(Italy), W. K. Landry et al (Germany),
and A. Reymunde (Puerto Rico) also
focused on small bowel tumors. Patients
were investigated via Capsule Endoscopy
for a variety of indications and suspected
small bowel diseases; the most common
was obscure GI bleeding (OGIB). Most
patients had undergone multiple negative
diagnostic procedures prior to CE.
Highlights of clinical findings on small bowel tumors, from presentations covering a total
of 1042 patients:
• 8.9% SBT in 562 patients
DIAGNOSING SMALL BOWEL TUMORS WITH CAPSULE
ENDOSCOPY
Blair S. Lewis, Mount Sinai Medical Center, New York, New York, USA
• 6% SBT in 270 patients
DIAGNOSIS OF SMALL BOWEL TUMORS WITH VIDEO CAPSULE
ENDOSCOPY - REPORT OF 16 CASES
Martin Keuchel, Allgemeines Krankenhaus Altona, Hamburg, Germany
• 7% SBT in 129 patients
INTEREST OF THE ENDOSCOPIC VIDEO-CAPSULE (VCE) TO
DETECT INTESTINAL TUMORS
Michel Delvaux, CHU Brabois, Nancy, France
• 7.4% SBT in 81 patients
DIAGNOSIS OF SMALL BOWEL TUMORS BY CAPSULE
ENDOSCOPY IN PATIENTS WITH OBSCURE GASTROINTESTINAL
BLEEDING
Ervin Toth, Malmo University Hospital, Malmo, Sweden
Types of tumors diagnosed via Capsule Endoscopy included adenocarcinoma, adenoma,
carcinoid, GI stromal tumor (GIST), hamartoma, hemangioma, inflammatory polyp,
melanoma, and metastastic tumors (from primary melanoma and lung cancer).
“This incidence of small bowel tumors suggests an important role for Capsule Endoscopy
in the algorithm for diagnostic work-up of suspected small bowel lesions. Capsule
Endoscopy may lead to earlier detection and treatment of small bowel tumors and improved
prognosis of these neoplasms.”
Blair S. Lewis, Mount Sinai Medical Center, New York, New York, USA
4
M2A ® Images
<strong>Small</strong> <strong>Bowel</strong>
<strong>Tumors</strong>
Melanoma
Carcinoid
Stromal Tumor
Courtesy of Blair S. Lewis,
Mount Sinai Medical Center,
New York, New York, USA

GI Bleeding
ICCE 2004 MIAMI CONFERENCE REPORT
In the 562-patient study on p. 4 by B. Lewis et al (USA),
88% of the patients had presented with anemia with the
bleeding type not telling. The annual incidence of GI bleeding
in the USA has been conservatively estimated at 100 episodes
per approximately 100,000 persons, accounting for 300,000
hospitalizations per year; the actual incidence may be higher5 .
According to recent publications1 , M2A Capsule Endoscopy
can significantly improve diagnosis for GI bleeding patients,
particularly for obscure GI bleeding (OGIB). Furthermore,
CE has led to alteration of diagnosis6 as well as alteration in
therapy7 .
New data on using CE for OGIB was presented at ICCE 2004.
This included the first multi-center study comparing CE to
intraoperative enteroscopy presented by G. Bolz et al
(Germany), which concluded complete diagnostic equivalence
PROSPECTIVE CONTROLLED TRIAL COMPARING
WIRELESS CAPSULE ENDOSCOPY WITH
INTRAOPERATIVE ENTEROSCOPY IN PATIENTS
WITH CHRONIC GASTROINTESTINAL BLEEDING:
ONGOING MULTI-CENTER STUDY
Georg Bolz, Klinikum Ludwigshafen, Ludwigshafen,
Germany
Complete diagnostic equivalence of CE to intraoperative
enteroscopy (IOE) was demonstrated in the study results
presented by G. Bolz for 42 patients with OGIB. Prior work-up
performed included upper endoscopy, colonoscopy, push
enteroscopy and small-bowel enteroclysis. All prior diagnostic
procedures showed no definitive bleeding source. Within
1 week of the CE examination IOE was carried out. The two
methods were evaluated independently. G. Bolz concluded:
“Based on these data, we suggest that patients with bleeding of
obscure origin and with negative bidirectional endoscopy are
candidates for the early use of CE.”
THE DIAGNOSTIC YIELD OF CAPSULE
ENDOSCOPY IN IRON DEFICIENCY ANEMIA (IDA)
Zvi Fireman, Hillel-Yaffe Medical Center, Hadera, Israel
This presentation focused on the superior diagnostic value of
CE for IDA. Z. Fireman summarized data for a 293-patient
study evaluating the diagnostic yield of CE vs other diagnostic
methods. Patients enrolled had persistent or recurrent iron
deficiency anemia; mean number of bleeding episodes was
4.3±5.5 and mean hemoglobin level was 9.8±2.4 g/dl. Average
number of diagnostic procedures per patient prior to CE was
5.59. Capsule Endoscopy detected definitive findings in
213/293 patients (72%) and missed findings detected by other
diagnostic procedures in 22/293 patients (8%). Neither CE nor
other diagnostic procedures yielded diagnoses in 58/293
patients (20%). Z. Fireman also presented a summary of recent
clinical data from other studies on IDA and evaluation of the
small bowel.
5
of the two methods and the “excellent diagnostic accuracy of
Capsule Endoscopy”. A major analysis of diagnostic yield of
CE for iron deficiency anemia (IDA) by Z. Fireman et al
(Israel) concluded 72% diagnostic yield for CE in 293 patients.
Many presentations and posters at ICCE 2004 reported OGIB
and anemia as primary indications or major presenting
conditions for suspected Crohn’s disease, small bowel tumors,
medication-induced lesions of the small intestine and other
pathologies. Patients had undergone from 4 to over 7
procedures/patient without diagnosis2 .
Based on available data, including new outcomes data (see
p. 6), presenters at ICCE strongly recommended early use of
CE for OGIB.
Diagnostic Equivalence
M2A ®
Capsule Endoscopy
Intraoperative
Enteroscopy
Courtesy of Georg Bolz, Klinikum Ludwigshafen,
Ludwigshafen, Germany

Outcomes & Patient Management
ICCE 2004 provided an opportunity for the presentation of a
significant amount of data on clinical outcomes after Capsule
Endoscopy, primarily for the obscure GI bleeding (OGIB)
indication. All speakers—presenters, panel members and
physicians during the Q&A sessions and working groups—
concluded that CE findings positively influence the
management of patients with OGIB. 2 This new data
substantiates initial outcomes data published by N. Goldfarb et
al (USA) 5 and A. Caunedo Alvarez, et al (Spain) 8 .
The presentation of the multi-national economic outcomes
study for the USA, Germany, France and Switzerland by R.
Bergemann et al (Germany) of the Institute of Medical
Outcomes Research (IMOR) showed that, from the healtheconomic
perspective, using CE as a first-line diagnostic tool
has cost-saving potential.
Pennazio et al (Italy) reported outcomes data for a long-range,
100-patient multi-center study and H. J. Schulz (Germany)
presented preliminary long-range outcomes results for a
ICCE 2004 MIAMI CONFERENCE REPORT
OUTCOME OF PATIENTS WITH OBSCURE GASTROINTESTINAL
BLEEDING AFTER CAPSULE ENDOSCOPY: REPORT OF 100
CONSECUTIVE CASES
Marco Pennazio, S. Giovanni Antica Sede Hospital, Turin, Italy
Study published in the March 2004 issue of Gastroenterology9 33-patient study. E. Carey presented clinical findings for D.
Fleischer et al (USA) for 1-year follow-up of 20 patients, noting
that OGIB resolved in a majority of the patients and there
was a significant reduction in number of transfusions,
hospitalizations and GI procedures; more than half the
patients felt that CE positively affected their condition.
During the Q&A session and in a poster, G. S. Raju et al (USA)
described a similar study, validating these figures.
Throughout the conference, physicians also discussed using
repeat Capsule Endoscopies on the same patient to
refine diagnosis for
challenging cases or
for patient followup
after initial
diagnosis. This is
becoming routine
patient management
following diagnosis
via CE.
As background to this study, M. Pennazio summarized CE follow-up data published and
presented by leading researchers. Mean follow-up for this long-range, 100-patient
outcomes study was 18 months (ranging from 12-25 months). Prior to CE, patients had
undergone 620 diagnostic tests—all with negative results. After CE, the most common
diagnoses via CE were angiodysplasia and Crohn’s disease. The study demonstrated values
of: 89% sensitivity (measured by number of positive diagnoses reached) and 95%
specificity (measured by number of negative final diagnoses reached).
M. Pennazio concluded: CE results led to treatments resolving the bleeding in 86.9% of
patients undergoing the procedure while actively bleeding. If done early in the course of
the workup, CE could shorten considerably the time to diagnosis, lead to definitive
treatment in a relevant proportion of patients and spare a number of alternative
investigations with low diagnostic yield.
PROSPECTIVE TRIAL COMPARING CAPSULE ENDOSCOPY WITH
INTRAOPERATIVE ENTEROSCOPY IN PATIENTS WITH CHRONIC
GASTROINTESTINAL BLEEDING - PRELIMINARY LONG TERM RESULTS
Hans Joachim Schulz, Oskar-Ziethen Hospital, Berlin, Germany
Outcomes data for the study (CE vs IOE) presented by G. Bolz, see p. 5
This presentation included clinical outcomes data for 33 patients, with mean follow-up of
310 days, with maximum of 553 days. H. J. Schulz concluded: Capsule Endoscopy
followed by a therapeutic intraoperative enteroscopy or surgical intervention is a very
precise and efficient diagnostic procedure in patients with severe chronic gastro-intestinal
bleeding. Depending on the underlying bleeding sources, the data emphasize excellent
diagnosis by CE and IOE and effective endoscopic and/or operative treatment; not in all
patients could recurrent bleeding be avoided.
6
M2A ® Images
Obscure
GI Bleeding (OGIB)
Active bleeding site visible
Courtesy of Marco Pennazio, S.
Giovanni Antica Sede Hospital,
Turin, Italy

ICCE 2004 MIAMI CONFERENCE REPORT
Emerging Indications & Applications
The ICCE continues to be the major forum for breaking research
on emerging indications and applications for Capsule Endoscopy.
New research areas introduced at the ICCE in previous years have
sparked additional research—leading to multi-national studies and
clinical trials which have, in turn, brought about approvals by
standards organizations and changes in healthcare and
reimbursement policies. Changing patient care algorithms for GI
bleeding and for diagnosing Crohn’s disease illustrate these
trends.
ICCE 2004 included clinical results of the first feasibility study
of M2A Esophageal Capsule Endoscopy * presented by A. R.
Eliakim (Israel) and the multi-center, multi-national study of the
M2A Patency System presented by M. E. Riccioni (Italy) and C.
Spada et al (Italy).
Other presentations on expanding indications included familial
adenomatous polyposis (FAP) by F. A. Macrae et al (Australia)
and F. H. Schnoll-Sussman et al (USA); for evaluating
medication-induced injury of the GI tract by J. Goldstein et
al (USA) and W. A. Qureshi (USA); and for managing acute
ESOPHAGEAL CAPSULE ENDOSCOPY (ECE) IS
COMPARED TO TRADITIONAL ENDOSCOPY FOR THE
EVALUATION OF PATIENTS WITH GERD SYMPTOMS
A. Rami Eliakim, Rambam Medical Center, Haifa, Israel
This feasibility study compared new technology for M2A Esophageal
Capsule Endoscopy (ECE) to traditional flexible endoscopy in detection
of esophageal pathologies, such as in patients with Gastroesophageal
Reflux Disease (GERD). It was reported that 12 of 17 patients studied
had positive esophageal findings using the gastroscope as the gold
standard. ECE identified esophageal pathology in all 12 patients, and
additional pathology in one patient that was missed by the gastroscope.
According to A.R. Eliakim, there were no swallowing problems and no
side effects. Based on this feasibility study, ECE is a convenient,
patient-friendly, sensitive method for visualizing esophageal disorders
and may provide an effective method to screen patients for Barrett’s
Esophagus. A multi-center study is under way.
EVALUATION OF THE GIVEN PATENCY SYSTEM IN THE
GI TRACT - RESULTS OF A MULTI-CENTER STUDY
Maria Elena Riccioni, University Catholic del Sacro Cuore, Rome, Italy
M. E. Riccioni presented clinical results of the multi-center, multinational
studies for evaluating intestinal patency with the M2A Patency
System, which consists of a disposable, ingestible M2A Patency
Capsule and hand-held M2A Patency Scanner. M. E. Riccioni
concluded: the new system gives direct indication of functional patency
even in cases where SBFT indicates physiological stricture; patients
with proven strictures pass the intact M2A Patency Capsule in a
relatively short time; when M2A Patency Capsule is excreted intact,
M2A video capsule passes naturally; M2A Patency Capsule is a simple,
radiation-free, ingestible diagnostic tool. It is optimal for clinical
situations where objective knowledge of intestinal patency is desirable
and can impact work-up: Crohn’s disease or post-radiation (strictures
not seen radiologically), post-operative, adhesion-related disease and
pre-M2A Capsule Endoscopy assessment.
* M2A Esophageal Capsule Endoscopy is investigational and not commercially available.
7
gastrointestinal graft vs host disease (GI-GVHD) after bone
marrow transplantation by V. Maunoury et al (France).
Ongoing clinical research suggests that celiac disease may be
under diagnosed and more prevalent than previously reported. 10,11,12
Intestinal cancer risk factors for certain celiac disease patients are
also being studied. 13 Presentations by P. Green (USA), P. Collin, et
al (Finland), N. Kraus et al (Germany) and S. Adler and H. Jacob
(Israel) focused on the role of CE in celiac disease for evaluating
and characterizing small bowel mucosal abnormalities in patients
with poorly-responsive or complicated celiac disease, ie, patients
on a gluten-free diet with recurrent symptoms, especially
abdominal pain.
Images of Long Segment
Barrett’s Esophagus
M2A Esophageal CE
Evaluating Patency
Stricture indicated
on X-ray
Celiac Disease
Traditional endoscopy
Courtesy of A. Rami Eliakim, Rambam Medical
Center, Haifa, Israel
M2A image of ileal ulcer
from same patient
Courtesy of Maria Elena Riccioni, University
Catholic del Sacro Cuore, Rome, Italy
Absent villi and serration
of mucosa characteristic
of celiac sprue
Courtesy of Peter Green,
Columbia University
Medical Center, New York,
New York, USA

ICCE 2004 MIAMI CONFERENCE REPORT
3 rd Annual ICCE Consensus
The 3 rd Annual ICCE Consensus allowed every participant to vote on key questions about important
clinical aspects of Capsule Endoscopy. Voting and tabulation of these results was via an electronic
survey tool.
Indications Clinical Practice
Crohn’s disease
• 83% CE will have an important
role in detecting and monitoring
Crohn’s disease
<strong>Small</strong> bowel tumors
• 87% CE will have an important
role for detection and screening
Obscure GI bleeding
• 76% CE before push
enteroscopy (PE) and small
bowel X-ray, after negative EGD
and colonoscopy
References
1. References & Abstracts. Available at:
http://www.givenimaging.com/Cultures/en-US/Given/english/Professionals/References/.
Accessed May 6, 2004.
2. 3rd <strong>International</strong> <strong>Conference</strong> on Capsule Endoscopy Program &
Abstracts. © 2004 Given Imaging Ltd.
3. Diez SF. Cardiac pacemaker: a real contraindication for capsule
endoscopy? Proceedings of the 2nd ICCE. 2003;11-12.
4. Leighton JA, Sharma VK, Srivathsan K, Heigh RI, McWane TL, Post
JK, Robinson SR, Bazzell JL, Fleischer DE. Safety of capsule
endoscopy in patients with pacemakers. Gastroint Endsoc. April
2004;59:567-569.
5. Goldfarb N, Phillips A, Conn M; Lewis BS; Nash DB. Economic and
health outcomes of capsule endoscopy: opportunities for improved
management of the diagnostic process for obscure bleeding. Dis
Manage. Sept 2002;5(3):123-135.
6. 11th UEGW, Madrid, 2003 cited by: Z. Fireman. The diagnostic yield
of capsule endoscopy in iron deficiency anemia. Presented at: ICCE
2004; March 1, 2004; Miami, Florida, USA.
7. Mylonaki M, Fritscher-Ravens A, Swain P. Wireless capsule
endoscopy: a comparison with push enteroscopy in patients with
ICCE 2004
was sponsored by
Given Imaging
Celiac disease
• 84% CE should be considered
for follow-up evaluation of
complicated celiac disease
Polyposis syndromes
• 77% CE may have an important
role in detection and monitoring
Irritable bowel syndrome (IBS)
with suspected organic disease
• 73% CE should be used for
evaluation
Copyright © 2004 Given Imaging Ltd. www.givenimaging.com All Rights Reserved. M2A, the M2A logo, PILLCAM, M2A THE
NATURAL WAY, RAPID and FINGERS HOLDING A CAPSULE Design are trademarks or registered trademarks of Given
Imaging Ltd. All other trademarks belong to their respective owners. GMM-0048-01
8
• 66% have decreased referrals
for small bowel X-ray and/or
enteroclysis
• 55% do not use any form of prep
• 77% do not use any prokinetic
• 76% Suspected Blood Indicator
(SBI) helps direct diagnosis
gastroscopy and colonoscopy negative gastrointestinal bleeding. Gut.
2003;502:1122-1126.
8. Caunedo Alvarez A, Rodriguez-Tellez M, Barroso Relinque N, Garcia
Montes JM, Pellicer Bautista FJ, Herrerias Gutierrez JM. Role of
capsule endoscopy in the management of patients with obscure
gastrointestinal bleeding. Rev Esp Enferm Dig. Aug 2002;94:482-92.
9. Pennazio M, Santucci R, Rondonotti E, Abbiati C, Beccari G, Rossini
FP, De Franchis R. Outcome of patients with obscure gastrointestinal
bleeding after capsule endoscopy: report of 100 consecutive cases.
Gastroenterol. Mar 2004;126:643-53.
10. Mäki M, Mustalahti K, Kokkonen J, Kulmala P, Haapalahti M,
Karttunen T, Ilonen J, Laurila K, Dahlbom I, Hansson T, Höpfl P,
Knip M. Prevalence of celiac disease among children in Finland.
N Engl J Med. Jun 2003;348:2517-2524.
11. Bingley PJ, Williams AJK, Norcross AJ, Unsworth DJ, Lock RJ, Ness
AR, Jones RW. Undiagnosed coeliac disease at age seven: population
based prospective birth cohort study. BMJ. 2004;328:322-323.
12. Green P. Celiac disease: the emerging role of capsule endoscopy.
Presented at: ICCE 2004; February 29, 2004; Miami, Florida, USA.
13. Schuppan D. Diagnostic imaging needs in the management of celiac
disease. Proceedings of the 2nd ICCE. 2003;31-33.
Thanks to those who contributed to the ICCE <strong>Conference</strong> Report. We apologize to those whose work we were unable to include due to constraints of publication time and
space. E-mail icce@givenimaging.com for future updates on the conference. See you at ICCE 2005.
Ellen F. Bodner
Editor, ICCE <strong>Conference</strong> Report