Abstract
Objectives: Photodynamic therapy (PDT) for unresectable cholangiocarcinoma reportedly results in reduction of cholestasis, improved quality of life, and improved survival. We report the effect of ERCP with PDT on survival in unresectable cholangiocarcinoma, using a cohort receiving only ERCP with biliary stenting for statistical comparison. Methods: Between December 2001 and November 2006, 48 patients aged 66 ± 13.4 years (range: 26-94) were palliated for unresectable cholangiocarcinoma. Nineteen were treated with PDT and stents (mean PDT session 1.6, range: 1-3); 29 patients treated with biliary stents alone served as a control group. Multivariate analysis was performed using MELD score, age, treatment by chemotherapy or radiation, number of ERCP and PDT to detect predictors of survival. Results: Patients in the stent group received a median number of 2 ERCPs (range: 1-13); in the PDT group, 3.0 (range: 1-8). Mean drop in serum bilirubin after 3 months was similar between both groups. Kaplan-Meier analysis demonstrated improved survival in the PDT group compared to the stent only group (16.2 months vs 7.4 months - p < 0.004). Mortality in the PDT group at 3, 6 and 12 months was 0%, 16% and 56% respectively. The corresponding mortality in the stent group was 28%, 52% and 82% respectively. The difference between the two groups was significant at 3 months (p < 0.01), 6 months (p < 0.01), but not at 12 months (p = 0.08). Only the number of ERCP and exposure to PDT were significant on multivariate analysis (Table 1). Adverse events specific to PDT included three patients with skin phototoxicity requiring topical therapy only. Conclusion: PDT is minimally invasive and effective in restoring biliary drainage in patients with unresectable cholangiocarcinoma. Survival appears prolonged when compared to stenting alone. It remains to be proven if this effect is attributable to PDT or multiple ERCP sessions. A prospective randomized multicenter study is required to define these issues. Tabled 1Factors predictive of survival Variable P value Odds ratio 95% CI Age 0.9001 0.998 0.969-1.028 Meld score 0.6947 1.016 0.938-1.102 PDT 0.0062 0.270 0.105-0.689 Chemotherapy 0.9285 1.074 0.228-5.059 Radiation 0.1850 0.308 0.054-1.757 ERCP sessions 0.0002 0.650 0.517-0.818 Open table in a new tab
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