Phase II study of photodynamic therapy and metal stent as palliative treatment for nonresectable hilar cholangiocarcinoma

Background. The combination of photodynamic therapy and biliary drainage by plastic endoprosthesis insertion has produced promising results in the treatment of nonresectable hilar cholangiocarcinoma. The feasibility and efficacy of intraductal photodynamic therapy with subsequent biliary drainage by self-expandable metal stent insertion were evaluated in a prospective phase II study. Methods: Twenty-four patients were treated with photodynamic therapy after sensitization with porfimer sodium. A plastic endoprosthesis was inserted immediately thereafter and replaced by a metal stent 4 weeks later. A retrospectively analyzed group of 20 patients treated only with biliary drainage served as a historical control group. Results: In 19 of the 24 patients, insertion of a metal stent was technically feasible. The 30-day and 60-day mortality rates were 0%. A significant decrease in serum bilirubin was noted in all patients and quality of life remained stable throughout follow-up. Mean and median survival were, respectively, 15.9(3.1) and 9.9: 95% CI [6.4,13.4] months after photodynamic therapy. In the control group, mean and median survival were, respectively, 12.5(3.4) and 5.6: 95% CI [3.7, 7.6] months, which was not statistically significantly different from the photodynamic therapy group. Conclusions: Photodynamic therapy with consecutive biliary drainage by insertion of a self-expandable metal stent is feasible. With respect to the small benefit in overall survival, randomized controlled trials are warranted.