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).

Conclusion: 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.

Keywords: Malignant biliary obstruction; endoscopic retrograde cholangiopancreatography; hilar cholangiocarcinoma; photodynamic therapy; therapeutic endoscopy.

Figures

Figure 1.

Stent patency. Calculation starts from the last electively performed photodynamic therapy (PDT) in each patient. Median stent patency was 269 days median for metal stents and 62 days median for plastic stents, p < 0.01.

Figure 2.

Kaplan–Meier survival curve of the study patients. Calculation starts on the day of the first photodynamic therapy. Median survival is 12.4 months (95% confidence interval (CI) 9.7–14.9 months).