Assessment of safety and adverse events in endoscopic radiofrequency ablation for malignant biliary obstruction.

Background: Endoscopic radiofrequency ablation (RFA) is used for the treatment of unresectable malignant biliary obstruction (MBO). The postoperative adverse events associated with RFA treatment have gained importance.

Objective: To investigate the early adverse events and their risk factors associated with RFA for the treatment of MBO.

Design: Observational retrospective study.

Methods: We collected data from patients diagnosed with MBO and treated with endoscopic RFA at our hospital between January 2010 and June 2022. Based on the collected data, the patients were divided into two groups: the adverse event group and the nonadverse event group. Early postoperative adverse events were recorded, and risk factors were assessed.

Results: One hundred and twenty patients with MBO underwent endoscopic RFA, with 20 developing adverse events (16.6%; 20/120). Among these, 13 patients (10.8%) developed biliary infection after RFA treatment, while 7 (5.8%) developed acute pancreatitis, and no bleeding or perforation occurred. Type 2 diabetes mellitus, bile duct stricture length >2.5 cm, segmental RFA, and the proportion of patients receiving single stent drainage were all significantly greater in the adverse event group compared to the nonadverse event group (p < 0.05). The results of the logistic regression analysis showed that type 2 diabetes, segmental RFA, and single stent drainage were the three independent risk factors for getting a biliary infection after RFA therapy.

Conclusion: Unresectable MBO combined with type 2 diabetes mellitus, segmental RFA, and postoperative single stent drainage can be the risk factors for adverse events after RFA. More attention should be paid to patients with multiple risk factors and preventive measures should be taken.