Efficacy and safety of percutaneous endobilliary radiofrequency ablation with a novel temperature-controlled catheter in malignant biliary strictures.

Purpose: The purpose of this study is to evaluate the efficacy and safety of temperature-controlled endobilliary radio-frequency ablation (EB-RFA) followed by metal stent placement for nonresectable malignant biliary strictures.

Material and methods: From May 2017 to March 2021, 18 patients with malignant biliary obstruction who had undergone percutaneous EB-RFA and stent placement (n = 9) or stent placement only (n = 9) were included in this retrospective study. Outcomes were stent patency, technical and clinical success, overall survival, and 30-day complication rate. Kaplan-Meier and Cox regression analyses were performed to examine the relationship of EB-RFA with stent patency and overall survival.

Results: The clinical and technical success rate for each group was 100%. The median stent patency was 128 days (95% CI: 122.2-133.8) in the EB-RFA group and 86 days (95% CI: 1.2-170.7) in the control group. It was significantly longer in the study group (p = 0.012). The mean overall survival was 267.7 ± 68.5 days (95% CI: 133.3-402.2) in the study group and 239.6 ± 33.9 days (95% CI: 173.1-306.2) in the control group. Log-rank test showed there was not a statistically significant difference in overall survival rates (p = 0.302). There were no major complications and no statistically significant difference in cholangitis rates (p = 0.620).

Conclusions: Percutaneous temperature-controlled EB-RFA combined with biliary stent placement for malignant biliary obstruction can be safe and feasible, and effectively increase stent patency.