Usefulness of intraductal RFA in patients with malignant biliary obstruction

BACKGROUND/AIMS: Intraductal radiofrequency ablation (ID-RFA) is a novel therapy for unresectable malignant biliary obstructions. ID-RFA for perihilar lesions is associated with a high risk of adverse events. We aimed to evaluate the feasibility and efficacy of temperature-controlled ID-RFA for perihilar malignant biliary obstruction. METHODS: Sixteen patients with pathologically proven perihilar cholangiocarcinoma were prospectively enrolled to evaluate the feasibility of hilar ID-RFA. Clinical efficacy and outcomes were subsequently evaluated in a multicenter retrospective cohort. RESULTS: Nine of the 16 patients in the prospective cohort had Bismuth type IV and 7 had type IIIA perihilar cholangiocarcinoma. The median length of stricture was 34.5 mm. The median number of ID-RFA sessions was three, and all sessions were technically and functionally successful without severe adverse events. Clinical outcomes were assessed using a multicenter hilar ID-RFA cohort of 21 patients; the median stent patency and overall survival were 90 days (range: 35–483 days) and 147 days (range: 92–487 days), respectively. An approximate 16-month patency of the bile duct was maintained in one patient who had an intraductal growth pattern. In a comparison of the self-expandable metallic stent (SEMS) and plastic stent (PS) after hilar ID-RFA, no differences in stent patency (89 vs 90.5 days, respectively; P = .912) and adverse events (20.0% vs 10%, respectively; P = .739) were observed. CONCLUSIONS: ID-RFA at 7 W for 120 seconds is safe and feasible in patients with advanced perihilar cholangiocarcinoma. After ID-RFA, SEMS and PS placement showed comparable patency and survival rates. TRIAL REGISTRATION NUMBER: KCT0003223