S262 Safety and Efficacy of Topical Hemostatic Agents (Powder/Gel) in the Management of Post-Sphincterotomy Bleeding: A Systematic Review and Meta-Analysis

Introduction: Endoscopic sphincterotomy and papillectomy are associated with post-procedural bleeding, with rates up to 45.3%. Achieving hemostasis using conventional management (CM) such as epinephrine injection, thermal coagulation, and hemoclips is often challenging due to limited access and maneuverability with the side-viewing duodenoscope. Recently, novel topical agents like PuraStat®, a self-assembling peptide-based gel, and hemostatic powders are easier to apply and have emerged as promising alternatives. We conducted a meta-analysis to assess the efficacy and safety of these agents in managing post-sphincterotomy bleeding (PSB). Methods: A comprehensive search of PubMed, Scopus, Embase, Medline, and Web of Science was conducted through April 2025. Studies reporting safety and efficacy of topical hemostatic agents (gel/powder) for PSB were included. Outcomes analyzed were successful primary hemostasis, delayed bleeding, total procedure time, and adverse event (AE) rates. A random-effects model was used for pooled estimates, and heterogeneity was assessed using I² statistics. Results: Six studies were included. 183 patients received either hemostatic gel/powder and 142 patients received CM for PSB. Indications for endoscopic retrograde cholangiopancreatography included CBD stone, malignant biliary obstruction, biliary drainage, ampullary mass, cholangioscopy and forceps biopsy. Mean PLT count, mean INR value and number of patients receiving anticoagulants/antiplatelet therapy were comparable between the groups. Overall rates of successful primary hemostasis and AE were 98% and 9% respectively among the patients who received hemostatic powder/gel. Rate of successful primary homeostasis was significantly different between the groups favoring hemostatic powder/gel (odds ratio [OR]: 0.22 [0.07-0.69]; P = 0.01, I2 = 0%). There was no significant difference in delayed bleeding rates (OR: 02.13 [0.74-6.13]; P = 0.16, I2 = 0%), total procedure time (MD: -0.31 [-4.44-3.82]; P = 0.88, I2 = 46%) and AE rates (OR: 0.68 [0.23-2.06]; P = 0.50, I2 = 0%) between the groups. Conclusion: Topical hemostatic agents are effective and safe alternatives to CM for PSB, offering higher rates of primary hemostasis without increasing delayed bleeding or AE risk. These agents may be a useful alternative to CM in terms of convenience and efficacy. Larger-scale randomized controlled trials are needed to better understand the efficacy of these agents—both in comparison to one another and for managing PSB in patients with surgically altered or challenging anatomy.