title: Photodynamic therapy with polyhematoporphyrin for malignant biliary obstruction: A nationwide retrospective study of 150 consecutive applications.
abstract: BACKGROUND
  Photodynamic therapy (PDT) is a palliative treatment for malignant biliary obstruction.
  
  
  OBJECTIVE
  The objective of this article is to assess the feasibility and safety of this technique.
  
  
  METHODS
  In this nationwide, retrospective study of prospectively collected clinical data, all patients treated with PDT using polyhematoporphyrin in Austria from March 2004 to May 2013 were included. Feasibility, adverse events, stent patency and mortality rates were investigated.
  
  
  RESULTS
  Eighty-eight patients (54 male, 34 female, median age 69 years) underwent 150 PDT procedures at seven Austrian referral centers for biliary endoscopy. The predominant underlying disease was Klatskin tumor (79/88). All PDT procedures were feasible without technical issues. Cholangitis was the most frequent adverse event (21/88). Stent patency was 246 days (95% CI 203-289) median and was significantly longer for metal than for plastic stents (269 vs. 62 days,p< 0.01). The median survival was 12.4 months (95% CI 9.7-14.9 m) calculated from first PDT and 15.6 months (95% CI 12.3-18.7 m) calculated from initial diagnosis. In patients suffering from biliary tract cancer, Cox regression revealed the number of PDT treatment sessions as the only independent predictor of survival at a multivariate analysis (p= 0.048).
  
  
  CONCLUSIONS
  PDT using polyhematoporphyrin was feasible and safe in this nationwide analysis. Survival data suggest a benefit of PDT in this unselected real-life patient population. Prospective trials comparing PDT to other palliative treatments will help to define its role in the management of malignant biliary obstruction. The study is registered at ClinicalTrials.gov number: NCT02504957.
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria.
authors.forename: Werner
authors.initials: W
authors.lastname: Dolak
authors.affiliation: Department of Internal Medicine II, Medical University of Innsbruck, Innsbruck, Austria.
authors.forename: Hubert
authors.initials: H
authors.lastname: Schwaighofer
authors.affiliation: Department of Internal Medicine IV, Wilhelminenspital, Vienna, Austria.
authors.forename: Brigitte
authors.initials: B
authors.lastname: Hellmich
authors.affiliation: Department of Internal Medicine I, Klinikum Wels-Grieskirchen, Wels, Austria.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Stadler
authors.affiliation: Department of Surgery, Barmherzige Schwestern Linz, Linz, Austria.
authors.forename: Georg
authors.initials: G
authors.lastname: Spaun
authors.affiliation: Department of Internal Medicine, Barmherzige Brüder St. Veit an der Glan, Austria.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Plieschnegger
authors.affiliation: Department of Internal Medicine I, Klinikum Klagenfurt am Wörthersee, Austria.
authors.forename: Arnold
authors.initials: A
authors.lastname: Hebenstreit
authors.affiliation: Department of Internal Medicine I, Klinikum Klagenfurt am Wörthersee, Austria.
authors.forename: Jutta
authors.initials: J
authors.lastname: Weber-Eibel
authors.affiliation: Department of Internal Medicine, Barmherzige Brüder St. Veit an der Glan, Austria.
authors.forename: Franz
authors.initials: F
authors.lastname: Siebert
authors.affiliation: Department of Surgery, Barmherzige Schwestern Linz, Linz, Austria.
authors.forename: Klaus
authors.initials: K
authors.lastname: Emmanuel
authors.affiliation: Department of Internal Medicine I, Klinikum Wels-Grieskirchen, Wels, Austria.
authors.forename: Peter
authors.initials: P
authors.lastname: Knoflach
authors.affiliation: Department of Internal Medicine IV, Wilhelminenspital, Vienna, Austria.
authors.forename: Michael
authors.initials: M
authors.lastname: Gschwantler
authors.affiliation: Department of Internal Medicine II, Medical University of Innsbruck, Innsbruck, Austria.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Vogel
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria.
authors.forename: Michael
authors.initials: M
authors.lastname: Trauner
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria.
authors.forename: Andreas
authors.initials: A
authors.lastname: Püspök
keywords: Malignant biliary obstruction; endoscopic retrograde cholangiopancreatography; hilar cholangiocarcinoma; photodynamic therapy; therapeutic endoscopy