Phase II study of photodynamic therapy and metal stent as palliative treatment for nonresectable XXXX .

@entity1 @entity648 @entity201 @entity1372
BACKGROUND: The combination of photodynamic therapy and biliary drainage by plastic endoprosthesis insertion has produced promising results in the treatment of nonresectable @entity201 . 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 @entity1 were treated with photodynamic therapy after sensitization with porfimer @entity1372 . A plastic endoprosthesis was inserted immediately thereafter and replaced by a metal stent 4 weeks later. A retrospectively analyzed group of 20 @entity1 treated only with biliary drainage served as a historical control group. RESULTS: In 19 of the 24 @entity1 , insertion of a metal stent was technically feasible. The 30-day and 60-day mortality rates were 0%. A significant decrease in serum @entity648 was noted in all @entity1 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.
