Usefulness of intraductal RFA in patients with malignant biliary obstruction

Abstract

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

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

“…19 With temperature-controlled RFA system, no severe AEs have been reported including in our study. [16][17][18][19][20] Through our animal experiment, we determined a safe and effective preset for perihilar ID-RFA. With this preset, every AE of the RFA group was mild to moderate, and AE rates did not differ between the two groups.…”

“…Therefore, a temperature‐controlled RFA system was newly developed to avoid this problem. To date, published data have shown no thermal injury‐related AE after a temperature‐controlled ID‐RFA in MBO 15‐19 …”

“…To date, published data have shown no thermal injury-related AE after a temperature-controlled ID-RFA in MBO. [15][16][17][18][19] Nevertheless, the applicability of ID-RFA in advanced MHBO remains unclear because data are still lacking. There has been no randomized trial in patients with MHBO.…”

Updated evidence on the clinical impact of endoscopic radiofrequency ablation in the treatment of malignant biliary obstruction

“…Since this study, 14 single-arm studies have been conducted to date (Table 1). 18,[26][27][28][29][30][31][32][33][34][35][36][37][38] Figueroa-Barojas et al and Wang et al revealed that after RFA, there was a significant increase in stricture diameter, 27,32 which is considered a measure of the effectiveness of RFA in prolonging stent patency. These studies reported a mean or median stent patency period ranging from 91.5-276 days.…”

“…T HE RATE OF AE of endoscopic RFA has been reported to be 4.2-35%. 18,[26][27][28][29][30][31][32][33][34][35][36][37][38][41][42][43][44][45][46][47] Since the definition of AE varies between studies, it is difficult to interpret these numbers in the context of a clinical setting. However, according to five reports comparing the rates of AE between patients treated with or without RFA, no significant difference was observed.…”