APPENDICES - NIHR Health Technology Assessment Programme

250
Appendix 16
Study details Population details Treatment details Results Interpretation
Authors’ conclusions Both APC and
PDT can ablate BO but for APC only half
as many treatment sessions needed
Brief study appraisal This small trial
was reported in abstract only and no
further full publication was located. Many
of the study details and methods were
unclear from the abstract and the quality
of the trial was therefore difficult to
assess. Treatment groups do not appear
comparable in terms of dysplasia
Mortality Not assessed
Morbidity Reduction of length was 90%
for PDT (range 0–100%) and 90% for APC
(range 50–100%)
AEs All patients with PDT developed
nausea and vomiting over a period of
4 hr after treatment. 4/10 PDT patients
showed transient dysphagia. No skin
phototoxity was found after PDT. There
was no vomiting in the APC group
but 3/10 patients developed transient
dysphagia and one mediastinal emphysema
and treatment had to be interrupted
Resource use Not assessed
Trial treatments PDT vs APC
Intervention PDT: 60 mg/kg bw of ALA.
Cylindrical diffuser fibre in the centre
of a balloon applicator and illuminated
using a diode laser system with 150 J/cm2 .
Number of treatment sessions was two
(1–5). Further PDT parameters were not
reported
Comparator APC: APC was applied with
a power of 70 W. The number of treatment
sessions was four (2–9)
Treatment
intention Curative
Type(s) of cancer
and histology Longsegment
BO
Main eligibility
criteria Not stated
Patient
characteristics
% Male: 65
Median age: 68 yr
Age range: 44–77 yr
PDT: 4/10 LGD, 6/10
HGD
APC: 5/10 LGD, 5/10
No dysplasia
Concomitant
treatment Not
stated
Authors Zoepf et al.
(2003) 101
Data source Abstract
Country Germany
Language English
Study design RCT
No. of participants
Total: 20
Intervention: PDT 10
Comparator: APC 10
No. of recruiting
centres Not stated
Follow-up period
and frequency
PDT: Median 27 mth,
range 12–42 mth
APC: Median 24 mth,
range 4–46 mth
bw, body weight.