S255 Comparison of a Novel Self-Assembling Peptide Gel and Conventional Techniques for Endoscopic Hemostasis in Post Sphincterotomy Bleeding: A Systematic Review and Meta-Analysis

Introduction: Bleeding after endoscopic sphincterotomy (ES) remains a major challenge. Standard endoscopic hemostatic procedures have demonstrated good performance for bleeding control. Recently, a novel self-assembling peptide hemostatic gel (PuraStat®) has been widely used in gastrointestinal bleeding. However, the safety and efficacy of this novel self-assembling peptide hemostatic gel remain unclear for bleeding after ES. We conducted a meta-analysis to compare the safety and efficacy of PuraStat® and conventional techniques for endoscopic hemostasis in post sphincterotomy bleeding. Methods: Several databases were reviewed from inception to Januray 18, 2025, to identify studies comparing the outcomes of PuraStat® and conventional techniques for post ES bleeding. Our outcomes of interest were initial hemostasis, rebleeding, and adverse events. We calculated risk ratios (RRs) with 95% CI for categorical variables and mean differences with 95% CI for continuous variables. Data was analyzed using the random effect model. Heterogeneity was assessed using I2 statistics. Results: We included 7 studies with 879 patients (PuraStat® 379, control 500) in our analysis. The mean age of the patients was 69.7 (9) years. Pooled rates of (95 CI%) of initial hemostasis with PuraStat® were 94.6% (88.2%, 97.6%), P = 0.4, I2 = 1%, rebleeding, 4.5% (0.9%, 19.1%), P = 0, I2 = 80%, and adverse events 6% (2%, 16.7%), P = 0.001, I2 = 75%. PuraStat® was associated with higher rates of initial hemostasis, RR (95 CI%), 1.02(0.89, 1.18), P = 0.75, I2 = 53%, and lower adverse events, RR (95 CI%), 0.68(0.15, 3.13), P = 0.62, I2 = 75%, however, results were not statistically significant. Comparative analysis of PuraStat® and conventional therapies showed that PuraStat® was associated with lower rates of rebleeding, RR (95 CI%), 0.35(0.13, 0.97), P = 0.04, I2 = 0%. Conclusion: Our meta-analysis demonstrates safety and efficacy of PuraStat® in endoscopic hemostasis in post ES bleeding, PuraStat® was associated with lower rates of rebleeding as compared to conventional therapies. Future multicenter studies are needed to validate these findings further.