APPENDICES - NIHR Health Technology Assessment Programme

278
Appendix 19
Study details Population details Treatment details Results Interpretation
Authors’
conclusions
PDT is minimally
invasive but there
is a considerable
risk of cholangitis
after the procedure.
PDT was found to
result in a substantial
prolongation of
survival time but
this would need
confirmation in
further patient
series. PDT has the
potential to result in a
changeover of current
palliative treatment
of BDC
Brief study
appraisal A
small trial with
clear reporting of
procedures. The
results appear to be
reliable but would
need confirmation in
a larger trial
Mortality The PDT group had a longer
survival time compared to the endoprosthesis
group (21 mth vs 7 mth, p = 0.01). In the PDT
group, 30-d mortality was 0% and 6% in the
endoprosthesis group. At the time of evaluation,
three patients in the PDT group and one in
the endoprosthesis group were still alive. The
PDT patients were deemed to be in good
clinical condition without significant cholestasis.
No details were provided on the survivor in
the endoprosthesis group. In the PDT group
12 patients died of tumour-related causes,
and one patient of a perforated gastric ulcer.
Causes of death were not reported for the
endoprosthesis group
Morbidity 4 wk after initial PDT, most
PDT patients showed an almost complete
elimination of bile duct stenosis in the treated
area as shown with cholangiography (data
not provided). Median bilirubin level after 1st
intervention was not significantly different
between the groups
QoL and return to normal activity QoL
as assessed by the Karnofsky scale did not
significantly improve after PDT
AEs Three patients developed an infected
bilioma with prolonged cholangitis after
PDT treatment, which could be managed
by antibiotic treatment. Another patient
developed cholecystitis 2 mth after a 2nd
treatment session, which led to surgical
laparoscopic cholecystectomy. There was no
skin phototoxicity observed in any of the
three patients. One patient developed severe
bacterial cholangitis during endoprosthetic
therapy, which was successfully treated by
standard antibiotic therapy
Resource use Not assessed
Trial treatments PDT + endoscopic
drainage vs Endoscopic drainage alone
Intervention Photosan-3 was given
intravenously at a dose of 2 mg/kg bw
48 hr before laser irradiation. A flexible
cylindrical diffuser probe was used. The
probe was mounted on a 400-µm quartz
fibre with an active length of 4cm and a
radiopaque marker at the distal fibre tip.
A diode laser system with a maximum
power output of 2 W and a wavelength
of 633 ± 3 nm was used as light source.
Irradiation time was calculated for a light
energy density of 200 J/cm2 . In most cases
this was around 550 s. the power density
was 450–500 mW/cm and energy dose
was 250–275 J/cm of diffuser length. For
transpapillary PDT the light applicator was
inserted through the working channel of
a duodenoscope. For percutaneous PDT
the quartz fibre was guided in four patients
through the partially removed percutaneous
catheter and in one patient through the
working channel of a cholangioscope.
The 1st PDT session was performed at a
median of 4.5 mth (1–9) after diagnosis of
BDC. Nine patients received a 2nd PDT
session after 3–9 mth and one patient a 3rd
session 6 mth after the 2nd session. Further
PDT parameters were not reported.
All patients were provided with plastic
endoprostheses immediately after the PDT
treatment
Comparator The aim of the
endoprosthetic treatment was bilateral hilar
drainage. Endoprostheses were regularly
changed every 3 mth or earlier in case of
clotting or dislocation
Treatment intention
Palliative
Main eligibility criteria
Advanced, non-resectable BDC
Patient characteristics
% Male: 63
Median age: 68 yr (range
52–80 yr)
Cancer stage: Stage II + lymph
nodes, one; stage IV, 31
Initial median Karnofsky
performance status: 90%
(70–100)
Overall 63% of cases were
confirmed histologically
Concomitant treatment All
patients received prophylactic
antibiotic treatment before
the procedure with 1 g of
Ceftriaxon, given intravenously
30 min before intervention.
Ongoing antibiotic oral
treatment with chinolone was
given for a total of 14 d. The
1st eight PDT patients had
intravenous Cefriaxon over 3 d
but did not receive continuing
oral antibiotic treatment
Authors Zoepf et al.
(2005) 136
Data source Full
published paper
Country Germany
Language English
Study design RCT
No. of participants
Total: 32
Intervention: 16
Comparator: 16
No. of recruiting
centres Not stated
Follow-up period and
frequency 1, 3, 6, 9, 12
and every 3 mth. Earlier
endoscopic interventions
were performed when
needed in case of clotting
or dislocation