APPENDICES - NIHR Health Technology Assessment Programme
APPENDICES - NIHR Health Technology Assessment Programme
APPENDICES - NIHR Health Technology Assessment Programme
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
DOI: 10.3310/hta14370 <strong>Health</strong> <strong>Technology</strong> <strong>Assessment</strong> 2010; Vol. 14: No. 37<br />
Study details Population details Treatment details Results Interpretation<br />
Authors’ conclusions<br />
ERCP with PDT<br />
seems to increase<br />
survival in patients<br />
with unresectable<br />
cholangiocarcinoma<br />
when compared with<br />
ERCP alone, although it<br />
remains to be proved<br />
whether this is due to<br />
PDT or the number or<br />
ERCP sessions<br />
Brief study appraisal<br />
The aims of this study<br />
at its inception are<br />
uncertain as the study<br />
began in 2001, but<br />
PDT only became<br />
available for use in<br />
2004. From this point<br />
on, PDT was offered<br />
to all patients, making<br />
it difficult to recruit<br />
groups with similar<br />
baseline characteristics.<br />
However, the authors<br />
acknowledged that the<br />
study design prevented<br />
definitive conclusions<br />
from being drawn<br />
Mortality At end of study 10 patients were still<br />
alive, eight being from the PDT group<br />
There was statistically significant prolonged<br />
survival in the PDT group (mean 16.2 mth, SD<br />
2.4) compared with the Stent-alone group (mean<br />
7.4 mth, SD 1.6), p < 0.003. Mortality rates were<br />
significantly lower in the PDT group at 3 mth (0%<br />
vs 28%, p = 0.01), and 6mth (16% vs 52%, p = 0.01),<br />
but not at 12 mth (56% vs 82%, p = 0.08) vs Stentalone<br />
group<br />
Morbidity Both groups had significantly decreased<br />
levels of serum bilirubin at 3 mth when compared<br />
to baseline levels (p = 0.008 for PDT and p = 0.0001<br />
for stent only), although there was no significant<br />
difference between the two groups in the degree<br />
of decrease (p = 0.78)<br />
QoL and return to normal activity Not<br />
assessed<br />
AEs Stent-alone group: 10 patients developed<br />
cholangitis (with two patients dying as a<br />
consequence). Four patients developed pancreatitis<br />
and one had duodenal perforation. Further results<br />
reported. PDT group: three patients experienced<br />
skin phototoxicity. Seven patients developed<br />
cholangitis, two developed cholecystitis, and two<br />
haemobilia. Further results reported<br />
Resource use Not assessed<br />
Trial treatments ERCP with PDT and stent vs<br />
ERCP with Stent alone<br />
Intervention Selective decompression of all<br />
opacified, dilated segments was attempted with<br />
bougie and balloon dilatation to assist in the<br />
placement of polyethylene stents<br />
Intravenous Photofrin at 2 mg/kg 48 hr prior to<br />
633-nm (± 3-nm) light from a 2000-mW diode<br />
laser, delivered through a 3-m length fibre having<br />
a 2.5-cm-long cylindrical diffuser at distal end<br />
(diffuser was inserted into a 10F sheath of a<br />
plastic stent)<br />
Photoactivation performed at 633 nm* with a<br />
light dose of 180 J/cm2 , fluence of 0.25 W/cm2 and<br />
duration of 750 s. One or two segments treated<br />
at discretion of endoscopist. PDT repeated at<br />
3-mth intervals when all stents were replaced<br />
(this was done earlier if premature occlusion or<br />
migration occurred)<br />
*Although reported as 620 nm in the paper, based<br />
on the type of laser used this appears to have<br />
been a typographic error<br />
Comparator Selective decompression of all<br />
opacified, dilated segments was attempted with<br />
bougie and balloon dilatation to assist in the<br />
placement of polyethylene stents (7F, 8.5F and<br />
10F in diameter). Repeated if indicated until<br />
patient refusal or death<br />
Treatment intention<br />
Palliative<br />
Type(s) of cancer and<br />
histology Non-resectable<br />
cholangiocarcinoma<br />
Main eligibility criteria<br />
Unclear, PDT offered after<br />
December 2004 to all<br />
patients with non-resectable<br />
cholangiocarcinoma or<br />
resectable lesions deemed<br />
inoperable<br />
Patient characteristics<br />
% Male: 50<br />
Age range: 26–94 yr<br />
Mean age: 66.6 yr<br />
Tumour extension: Bismuth<br />
I, 6%; Bismuth II, 19%;<br />
Bismuth III, 35%; Bismuth<br />
IV, 40%<br />
Further patient<br />
characteristics were<br />
reported<br />
Pathological diagnosis was<br />
confirmed in 69% of cases<br />
Concomitant treatment<br />
Twenty-two patients had<br />
chemotherapy and 19 had<br />
radiotherapy. All patients<br />
received periprocedure<br />
antibiotic prophylaxis<br />
Authors Kahaleh<br />
et al. (2008) 133<br />
Data source Full<br />
published paper<br />
Country USA<br />
Study design<br />
Non-RCT<br />
No. of<br />
participants<br />
Total: 48<br />
Intervention: 19<br />
Comparator: 29<br />
No. of recruiting<br />
centres One<br />
Follow-up<br />
period and<br />
frequency FU at<br />
1 mth and every<br />
3 mth thereafter<br />
(or earlier if<br />
there were<br />
complications)<br />
© 2010 Queen’s Printer and Controller of HMSO. All rights reserved.<br />
F, The ‘French size’ of the sheath used to introduce a stent.<br />
275