Fully covered self-expandable metal stents versus multiple plastic stents for the treatment of post-orthotopic liver transplant anastomotic biliary strictures: An updated systematic review and meta-analysis of randomized controlled trials.
Baraldo, S., et al.Surgical Endoscopy 2025; 39(2): 721-729.
Aims
To compare the efficacy, safety, and cost-effectiveness of fully covered self-expandable metal stents (fcSEMS) versus multiple plastic stents (MPS) in the endoscopic management of post–orthotopic liver transplant (OLT) anastomotic biliary strictures (ABS), focusing on key outcomes such as stricture resolution, recurrence, procedure-related adverse events, total treatment duration, number of ERCP sessions, and overall costs.
Interventions
Intervention Arm: fcSEMS placement (fully covered self-expandable metal stents), typically requiring 2 ERCP sessions: one for stent insertion and another for removal. Control Arm: MPS (multiple plastic stents), inserted and upsized over multiple ERCP sessions until achieving adequate bile duct caliber.
Participants
5 randomized controlled trials (RCTs) were included (n=245 total). All trials enrolled adult OLT recipients who developed an anastomotic biliary stricture and underwent endoscopic therapy.
Outcomes
Primary outcome was stricture resolution rate. Secondary outcomes included: stricture recurrence rate, number of ERCP sessions required, overall treatment duration (time from first intervention to stent removal/final resolution), adverse events (AEs) – e.g., pancreatitis, cholangitis, perforation and cost (in thousands of US dollars).
Follow-up
up to 12-24 months
CET Conclusions
The authors present a methodologically sound systematic review and subsequent meta-analysis of the available literature. The meta-analysis is restricted to RCTs, improving internal validity. Low to moderate heterogeneity for most outcomes; with moderate to high certainty of evidence based on GRADE. Some outcomes displayed high I², but sensitivity analyses showed these results to be robust to single-study exclusions, overall demonstrating a good quality of evidence. With regards the outcomes across the study, for stricture resolution fcSEMS and MPS were equally effective (RR ~0.99; p=0.86). Stricture recurrence had no significant difference (RR ~2.22, p=0.16), though the point estimate numerically favored MPS, but heterogeneity was moderate (I²=52%). For ERCP sessions, fcSEMS required significantly fewer ERCPs compared to MPS (mean difference ≈−1.7 sessions, p=0.005). Treatment Duration for fcSEMS had a shorter overall treatment course by ~96 days (p=0.03). Some. Adverse Events (AEs) were no different in overall complications (p=0.82) or specific events (e.g., pancreatitis, cholangitis). The costs were analysed by 3 RCTs, finding no statistically significant difference in pooled estimates (p=0.16), though sensitivity analysis suggested fcSEMS might be cheaper if one of the high-heterogeneity studies that was excluded. Overall, both fcSEMS and MPS achieve comparable stricture resolution and safety in post-OLT ABS. However, fcSEMS significantly reduces the number of ERCP sessions and overall treatment duration, thus appearing a more convenient alternative. Aggregate costs show no robust statistical difference, but reduced patient burden (and potentially indirect costs) may favour fcSEMS in clinical practice, making it a preferable alternative for ABS after OLT.
Trial registration
PROSPERO - CRD42023469281