Impact of Radiofrequency Ablation on Uncovered Metal Stent Patency in Malignant Biliary Obstruction from Pancreatic Cancer

Background and study aims: Pancreatic ductal adenocarcinoma (PDAC) with malignant biliary obstruction is frequently unresectable and carries a median survival of less than one year. Uncovered self-expandable metal stents (UCSEMS) are standard for biliary decompression but are limited by tumor ingrowth. Temperature-controlled endobiliary radiofrequency ablation (TC-RFA) has been proposed to prolong stent patency. We evaluated the efficacy and safety of TC-RFA followed by UCSEMS compared with UCSEMS alone for PDAC-related biliary stricture. Patients and methods: In this single-center study, PDAC patients were prospectively treated with TC-RFA plus UCSEMS and compared with a retrospective cohort treated with UCSEMS alone. The primary outcome was time to recurrent biliary obstruction (TRBO) within six months. Secondary outcomes included technical and clinical success, adverse events (AEs), surgical resection, and mortality. Results: Among 176 patients, 129 received UCSEMS alone and 47 received TC-RFA plus UCSEMS. Technical success was higher with UCSEMS alone (100% vs. 95.7%; p = 0.02), while clinical success was similar between groups (94.4% vs. 95.7%; p = 0.72). Six-month cumulative incidence of recurrent biliary obstruction (RBO) was significantly higher with TC-RFA (56.5% vs. 24.0%; p<0.001), with tissue ingrowth the most common cause. AEs, surgical resection, and mortality did not differ between groups. Conclusions: TC-RFA before UCSEMS placement was safe but associated with shorter TRBO and higher RBO incidence, without improvement in surgical or survival outcomes. These findings do not support routine TC-RFA for PDAC-related biliary strictures. ClinicalTrials.gov: NCT05826639.