Endobiliary radiofrequency ablation in recurrence and unresectable perihilar cholangiocarcinoma

Background: Palliative biliary stenting is the principal treatment for unresectable perihilar cholangiocarcinoma (pCCA) patients who suffer from jaundice. Endobiliary radiofrequency ablation (EBRFA) is the novel treatment in combination with biliary stenting for CCA with the intention to extend the patency and survival of patients which is a lack of knowledge and evident base data for perihilar CCA. This study aims to investigate the safety of EBRFA and efficacy in terms of increasing stent patency and the patient’s survival. Methods: Patients with unresectable perihilar CCA were prospectively randomized into 2 groups including EBRFA with self-expandable metallic stent (SEMS), and SEMS alone. Stent patency time was recorded after stent implantation and until obstructive jaundice occurrence. The median survival time (MST), median stent patency, and adverse event rate were analyzed and compared using Log-rank test. The proportion comparisons of patient characteristics, preoperative testing, procedure detail, and morbidity in two methods were conducted by Chi-squad test. Result: Of a total of 39 patients who were diagnosed pCCA and included in this study, 22 patients were in the EBRFA group and 17 patients in SEMS group. The procedure-related complication rate was not statistically significant different between EBRFA and the SEMS groups. There was no statistically significant difference of stent patency time between EBRFA and SEMS groups (71 vs 78 days, p-value =0.809), as well as The OS of EBRFA group had no statistically significant difference with SEMS group, (94 vs 79 days, HR= 1.31, 95%CI: 0.66-2.58, p-value =0.735). Conclusion: The EBRFA was shown to be safe to use and practical to perform combined with SEMS for treatment unresectable pCCA. Trial registration: TCTR20190704002