Self-expandable metal stent (SEMS) with iodine-125 intraluminal brachytherapy versus SEMS alone for unresectable malignant distal biliary obstruction: survival and patency analysis
Year: 2026
Type: article
Study design: Observational Study
Abstract: Background: In patients with unresectable malignant biliary obstruction, brachytherapy combined with self-expandable metal stents (SEMS) has demonstrated extended stent patency and survival. However, researches rarely evaluate the outcomes of brachytherapy combined with subsequent systemic therapy, and most obstruction sites are located in the hilar bile ducts. The extrahepatic biliary tract lacks intrinsic structural support, limiting the application of locoregional therapies and predisposing to rapid clinical deterioration if drainage is delayed. The purpose of this study is to investigate the utility of SEMS combined with 125I brachytherapy in the treatment of unresectable malignant distal biliary obstruction (MDBO), providing evidence to guide locoregional management of this patient population.Methods: This study retrospectively enrolled 187 patients first diagnosed with unresectable MDBO undergoing SEMS treatment at our center between August 2020 and July 2024. The brachytherapy group simultaneously received iodine-125 seed implantation (53 patients), while the control group received only SEMS placement (134 patients). We collected comprehensive clinicopathological data, including demographics, tumor characteristics, hepatic function, Eastern Cooperative Oncology Group (ECOG) performance status, and subsequent anticancer therapies. The study endpoints included overall survival and stent patency time. The duration of patency and overall survival was calculated using the Kaplan-Meier method, and the risk factors were assessed using the Cox proportional hazards models.Results: The stent patency in the brachytherapy group was significantly longer than that in the control group [275 and 168 days, hazard ratio (HR) =0.50, 95% confidence interval (CI): 0.29–0.88, P=0.01]. The overall survival in the brachytherapy group was significantly longer than that in the control group (208 and 152 days, HR =0.60, 95% CI: 0.39–0.93, P=0.02). Furthermore, the combination of brachytherapy and subsequent systemic therapy significantly improved both stent patency (P=0.02) and overall survival (P=0.001) compared to monotherapy.Conclusions: 125I brachytherapy appears more effective than stent placement alone in regard to stent dysfunction and survival in this MDBO cohort. Moreover, 125I brachytherapy followed by subsequent systemic therapy is associated with further extensions in patient survival and stent patency.
Language: English
Subfield: Gastroenterology
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W7224130665
