Efficacy and safety of temperature‐controlled intraductal radiofrequency ablation in advanced malignant hilar biliary obstruction: A pilot multicenter randomized comparative trial
Huapyong Kang, Sung Yong Han, Jae Hee Cho, Eui Joo Kim, Dong Uk Kim, Jae Kook Yang, Soyoung Jeon, Goeun Park, Tae Hoon Lee
Abstract
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.