Randomized Trial Comparing Radiofrequency Ablation and Photodynamic Therapy for Treating Inoperable Hilar Cholangiocarcinoma

What this Trial Is About

This research aims to compare two treatments for patients with hilar cholangiocarcinoma, a type of bile duct cancer often diagnosed late when surgery is not an option. The study evaluates survival outcomes between photodynamic therapy PDT and radiofrequency ablation RFA combined with stent placement, focusing also on side effects and quality of life. These treatments work by killing cancer cells through different methods applied during an endoscopic procedure. All participants will undergo stenting via endoscopic retrograde cholangiopancreatography ERCP to keep bile ducts open. One group will receive at least one PDT session, which involves injecting a photosensitizer absorbed by tumor cells followed by light application to kill the cancer. The other group receives RFA through ERCP, using heat generated by electrical current to destroy cancer cells. Additional stents will be placed if necessary after either treatment. Participants will be monitored for overall survival, stent function, quality of life, and laboratory parameters over about one year, with some measures extending to two years. Assessments include patient-reported itching, blood tests, and evaluations of bile duct status. The study collects data on survival time, hospital days, and quality-adjusted life years to understand treatment impact. Safety and side effects will be followed closely throughout the trial.

Treatment of Non-resectable Bile Duct Cancer with Radiofrequency Ablation or Photodynamic Therapy