Benign biliary strictures and bile leaks remain challenging clinical conditions, frequently managed with plastic or metal stents, which require endoscopic retrieval(1). Biodegradable biliary stents (BDBS) offer an innovative, non-removable alternative, potentially reducing the need for repeat procedures(2). This systematic review aimed to evaluate the effectiveness and safety of BDBS in managing benign biliary strictures and post-cholecystectomy bile leaks, identifying pooled success and complication rates, and assessing the quality of existing evidence.

A systematic literature review was performed using PubMed, Scopus, and Web of Science databases, covering studies from January 2000 to March 2025. Search terms included “biodegradable stents,” “benign biliary stricture,” and “bile leak.” Inclusion criteria comprised original human studies reporting outcomes of BDBS in benign biliary conditions. Excluded were animal studies, case reports, editorials, and studies on malignant strictures. Four eligible studies met inclusion criteria, encompassing both prospective and retrospective designs. Key outcomes extracted were clinical success (defined as resolution of stricture or leak without need for reintervention) and complication rates (e.g., stent migration, occlusion, incomplete degradation). This systematic review has been prospectively registered in PROSPERO (Registration number: CRD420251084759.

A total of 115 patients were included across four studies. The pooled clinical success rate for biodegradable biliary stents was 85.07% (95% CI: 77.68%–92.45%), with no significant heterogeneity (I² = 0%), suggesting consistency across studies. The pooled complication rate was 14.81% (95% CI: 7.54%–22.09%), reflecting a moderate but acceptable safety profile. The most common adverse events reported included stent migration (10–15%) and incomplete degradation (up to 18%). Importantly, no major procedure-related mortality was reported across any of the included studies. Subgroup analysis revealed a slightly higher clinical success rate in post-cholecystectomy bile leak cases (90%) compared to those with benign biliary strictures (ranging between 82% and 88%), although the sample sizes were limited.

This review supports the clinical utility of biodegradable biliary stents as a safe and effective option for benign biliary strictures and bile leaks. With a high pooled success rate and acceptable complication profile, BDBS may reduce the burden of repeated endoscopic procedures. However, further high-quality prospective trials are needed to optimize stent design, reduce migration risk, and establish long-term outcomes across diverse patient populations. These findings may inform future guideline development and enhance biliary care pathways.