Efficacy and safety of temperature-controlled intraductal radiofrequency ablation in advanced malignant hilar biliary obstruction: A pilot multicenter randomized comparative trial.

PURPOSE: We aimed to evaluate the efficacy and safety of temperature-controlled intraductal radiofrequency ablation (ID-RFA) for advanced malignant hilar biliary obstruction (MHBO).

METHODS: Patients were randomly assigned to RFA group (ID-RFA and bilateral plastic stent [PS]) or non-RFA group (bilateral PS) at a 1:1 ratio. Exchange to self-expanding metal stent (SEMS) was performed after 3 months or when premature PS occlusion occurred. Total event-free stent patency, overall survival (OS), and adverse events (AEs) were analyzed.

RESULTS: A total of 30 patients from three hospitals were enrolled. Stent patency and OS did not differ between the two groups (178 days vs 122 days, P = .154; 230 days vs 144 days, P = .643; respectively). In patients with each stricture length ≥11 mm on both sides, stent patency was longer in the RFA group than in the non-RFA group (175 days vs 121 days, P = .028). More patients received elective exchange to SEMS without PS occlusion in the RFA group than in the non-RFA group (69.2% vs 23.1%, P = .018). AE rates did not differ between the two groups.

CONCLUSIONS: Temperature-controlled ID-RFA for advanced MHBO was safe and feasible. It could prevent premature PS occlusion within 3 months.