APPENDICES - NIHR Health Technology Assessment Programme

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274 Appendix 19 Study details Population details Treatment details Results Interpretation Authors’ conclusions PDT has the potential to considerably prolong survival in non-resectable bile duct cancer. The effect is not dependent on the type of haematoporphyrin photosensitiser Brief study appraisal This study was reported in abstract form only and did not provide details of methodology such as randomisation, blinding and allocation concealment. This is a small trial which may be underpowered to detect a difference between the photosensitisers Mortality Median survival in the PS-3 group was 690 d (95% CI 448 to 931) and in the PF2 group it was 494 d (95% CI 84 to 903), p = NS Morbidity Not assessed QoL and return to normal activity Not assessed AEs There was no substantial skin reaction observed (no data provided). 23% of patients in the PF2 group and 26% of patients in the PS3 group developed ‘considerable’ cholangitis Resource use Not assessed Trial treatments PDT with Photosan-3 vs PDT with Photofrin II Intervention 2 mg/kg Photosan-3 administered 48 hr before radiation. A 4-cm quartz fibre and a diode laser system (635 nm; 1, 1 W, 220 J/cm). Light protection was advised for 4–6 wk. Further PDT parameters were not reported Comparator 2 mg/kg Photofrin II administered 48 hr before radiation. A 4-cm quartz fibre and a diode laser system (635 nm; 1, 1 W, 220 J/cm). Light protection was advised for 4–6 wk. Further PDT parameters were not reported Treatment intention Palliative Type(s) of Cancer and Histology Non-resectable bile duct cancer Main Eligibility Criteria Advanced bile duct cancer (no further details given) Patient characteristics % Male: 76 Median age: 67–70 Histological confirmation was not reported Concomitant treatment Peri-interventional antibiotic prophylaxis Authors Dechene et al. (2007) 132 Data source Abstract Country Not stated Language English Study design Non-RCT No. of participants Total: 29 Intervention: 16 Comparator: 13 No. of recruiting centres Not stated Follow-up period and frequency Not stated
DOI: 10.3310/hta14370 Health Technology Assessment 2010; Vol. 14: No. 37 Study details Population details Treatment details Results Interpretation Authors’ conclusions ERCP with PDT seems to increase survival in patients with unresectable cholangiocarcinoma when compared with ERCP alone, although it remains to be proved whether this is due to PDT or the number or ERCP sessions Brief study appraisal The aims of this study at its inception are uncertain as the study began in 2001, but PDT only became available for use in 2004. From this point on, PDT was offered to all patients, making it difficult to recruit groups with similar baseline characteristics. However, the authors acknowledged that the study design prevented definitive conclusions from being drawn Mortality At end of study 10 patients were still alive, eight being from the PDT group There was statistically significant prolonged survival in the PDT group (mean 16.2 mth, SD 2.4) compared with the Stent-alone group (mean 7.4 mth, SD 1.6), p < 0.003. Mortality rates were significantly lower in the PDT group at 3 mth (0% vs 28%, p = 0.01), and 6mth (16% vs 52%, p = 0.01), but not at 12 mth (56% vs 82%, p = 0.08) vs Stentalone group Morbidity Both groups had significantly decreased levels of serum bilirubin at 3 mth when compared to baseline levels (p = 0.008 for PDT and p = 0.0001 for stent only), although there was no significant difference between the two groups in the degree of decrease (p = 0.78) QoL and return to normal activity Not assessed AEs Stent-alone group: 10 patients developed cholangitis (with two patients dying as a consequence). Four patients developed pancreatitis and one had duodenal perforation. Further results reported. PDT group: three patients experienced skin phototoxicity. Seven patients developed cholangitis, two developed cholecystitis, and two haemobilia. Further results reported Resource use Not assessed Trial treatments ERCP with PDT and stent vs ERCP with Stent alone Intervention Selective decompression of all opacified, dilated segments was attempted with bougie and balloon dilatation to assist in the placement of polyethylene stents Intravenous Photofrin at 2 mg/kg 48 hr prior to 633-nm (± 3-nm) light from a 2000-mW diode laser, delivered through a 3-m length fibre having a 2.5-cm-long cylindrical diffuser at distal end (diffuser was inserted into a 10F sheath of a plastic stent) Photoactivation performed at 633 nm* with a light dose of 180 J/cm2 , fluence of 0.25 W/cm2 and duration of 750 s. One or two segments treated at discretion of endoscopist. PDT repeated at 3-mth intervals when all stents were replaced (this was done earlier if premature occlusion or migration occurred) *Although reported as 620 nm in the paper, based on the type of laser used this appears to have been a typographic error Comparator Selective decompression of all opacified, dilated segments was attempted with bougie and balloon dilatation to assist in the placement of polyethylene stents (7F, 8.5F and 10F in diameter). Repeated if indicated until patient refusal or death Treatment intention Palliative Type(s) of cancer and histology Non-resectable cholangiocarcinoma Main eligibility criteria Unclear, PDT offered after December 2004 to all patients with non-resectable cholangiocarcinoma or resectable lesions deemed inoperable Patient characteristics % Male: 50 Age range: 26–94 yr Mean age: 66.6 yr Tumour extension: Bismuth I, 6%; Bismuth II, 19%; Bismuth III, 35%; Bismuth IV, 40% Further patient characteristics were reported Pathological diagnosis was confirmed in 69% of cases Concomitant treatment Twenty-two patients had chemotherapy and 19 had radiotherapy. All patients received periprocedure antibiotic prophylaxis Authors Kahaleh et al. (2008) 133 Data source Full published paper Country USA Study design Non-RCT No. of participants Total: 48 Intervention: 19 Comparator: 29 No. of recruiting centres One Follow-up period and frequency FU at 1 mth and every 3 mth thereafter (or earlier if there were complications) © 2010 Queen’s Printer and Controller of HMSO. All rights reserved. F, The ‘French size’ of the sheath used to introduce a stent. 275
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APPENDICES - NIHR Health Technology Assessment Programme

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