Objectives: Preliminary uncontrolled studies of photodynamic therapy (PDT) of bile duct cancer (BDC) have shown astonishingly good results in the reduction of cholestasis, improvement of life quality, and potential improvement of survival time. Therefore, we investigated the influence of PDT on survival time in advanced BDC in a randomized controlled study.
Methods: Thirty-two patients with nonresectable BDC were randomized. In the PDT group 48 h after intravenous application of 2 mg/kg body weight of Photosan-3((R)), light activation was performed. In the control group, patients were treated with endoprostheses but no PDT.
Results: PDT group and the control group were comparable due to age, gender, performance status, bilirubin level, and BDC stage (Bismuth classification). The median survival time after randomization was 7 months for the control group and 21 months for the PDT group (p= 0.0109). In half of the initially percutaneously treated patients, we could change from percutaneous to transpapillary drainage after PDT. Four patients showed infectious complications after PDT versus one patient in the control group.
Discussion: PDT is minimally invasive but shows a considerable postinterventional cholangitis rate. PDT has the potential to result in a changeover of current palliative treatment of BDC.