APPENDICES - NIHR Health Technology Assessment Programme

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Appendix 16
Study details Population details Treatment details Results Interpretation
Authors’ conclusions ALA–PDT can
provide safe and effective ablation of lowgrade
dysplastic epithelium
Brief study appraisal This small study
was generally well conducted, and the
results appear reliable. However, it should
be noted that no results appear to have
been reported on AEs in the placebo
group, and it was unclear to which FU
the main study results relate
Mortality Not assessed
Morbidity In the PDT group 16/18
(89%) showed macroscopic evidence of
regression at FU endoscopy, compared
with 2/18 (11%) in the placebo group;
the corresponding median reduction
in areas were 30% for PDT vs 0% for
placebo (both p < 0.001). All regression
cases displayed normal squamous mucosa
when biopsied. There was a reduction in
prevalence of dysplasia in favour of the
PDT group (0/18 vs 12/18, p < 0.001).
Although it was unclear as to which FU
point these results relate to, the authors
did state that the effects of treatment
were maintained for up to 24 mth
AEs All PDT patients experienced chest
pain during treatment that persisted for
3–5 d, and was aggravated by swallowing
or coughing. One patient developed a
mild skin rash on exposure to sunlight
(resolved within 48 hr). No patients
complained of dysphagia. No results
appeared to have been reported for the
placebo group
Resource use Not assessed
Trial treatments ALA–PDT vs
Placebo-PDT
Intervention Patients drank 30 mg/
kg ALA (dissolved in 50 ml of orange
juice) followed 4 hr later by laser
endoscopy (under intravenous sedation
and analgesia) when the extent of
Barrett’s area was recorded. A copper
vapour laser delivered by a fibre with
a diffuser tip was used to deliver green
light (514 nm) at a power density of
120 mW/cm2 for 500 s per 3-cm length.
All patients had two separate treatments
(distal, then proximal, total treatment
time 1000 s, energy density 60 J/cm2 ) so
that 6 cm of oesophagus was treated
(upper 6 cm of Barrett’s mucosa). This
represented complete treatment of
Barrett’s epithelium in one-half of the
patients. Patients remained in hospital
until dark, and were advised to avoid
bright light for 24 hr
Comparator As for above, except
orange juice alone was used as placebo
Treatment intention
Curative
Type(s) of cancer and
histology BO – LGD
Main eligibility criteria
Patients with LGD in
circumferential BO of at least
3 cm in length, who were
receiving omeprazole were
eligible. However, histological
re-examination after biopsy
had to confirm the diagnosis
Patient characteristics
% Male: 83
Age range: 30–71 yr
Median age: 56 yr
Range of pre-treatment
lengths of Barrett’s: 3–15 cm
Concomitant treatment
Patients were given analgesic
and antiemetic drugs as
required following treatment.
Patients were also supplied
with antacids to take as
needed. Throughout the
treatment and FU period
patients were maintained on
20 mg omeprazole daily
Authors Ackroyd
et al. (2000) 95
Data source Full
published paper
Country UK
Language English
Study design
RCT
No. of
participants
Total: 36
Intervention: 18
Comparator: 18
No. of recruiting
centres Not
stated
Follow-up period
and frequency
FU at 1, 6, 12 and
24 mth
BO, Barrett’s oesophagus.