title: Phase II study of photodynamic therapy and metal stent as palliative treatment for nonresectable hilar cholangiocarcinoma.
abstract: 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.
authors.affiliation: Department of Medicine I, University of Bonn, Bonn, Germany.
authors.forename: Franz Ludwig
authors.initials: FL
authors.lastname: Dumoulin
authors.forename: Thomas
authors.initials: T
authors.lastname: Gerhardt
authors.forename: Sybille
authors.initials: S
authors.lastname: Fuchs
authors.forename: Christian
authors.initials: C
authors.lastname: Scheurlen
authors.forename: Michael
authors.initials: M
authors.lastname: Neubrand
authors.forename: Günter
authors.initials: G
authors.lastname: Layer
authors.forename: Tilman
authors.initials: T
authors.lastname: Sauerbruch
mesh_terms: D000368:Aged; D001650:Bile Duct Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D001653:Bile Ducts, Intrahepatic; D018281:Cholangiocarcinoma / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010166:Palliative Care; D010778:Photochemotherapy; D011446:Prospective Studies; D015607:Stents