Topical tranexamic acid and sucralfate prevent delayed bleeding after endoscopic sphincterotomy: a randomized controlled trial (with video)

Background: Endoscopic sphincterotomy (EST) is a standard treatment for choledocholithiasis. However, this approach carries a risk of delayed bleeding, which occurs in 2%–12% of all patients within 14 days postoperatively. Despite this risk, few effective measures are currently available for preventing delayed bleeding. Objectives: Tranexamic acid (TXA) is an antifibrinolytic agent that promotes hemostasis, and sucralfate is an antiulcer agent that forms a protective barrier over wounds. In this study, we investigated whether topical TXA and sucralfate application on post-EST wounds reduces the risk of delayed bleeding. Design: This prospective randomized controlled trial was conducted between December 2023 and December 2024 at a tertiary center. Methods: This study included patients with a naïve biliary major papilla and choledocholithiasis who were scheduled for EST. Patients who had unsuccessful common bile duct cannulation, were scheduled for biliary stent insertion without a sphincterotomy, underwent endoscopic papillary balloon dilatation instead of EST, or had any known biliary or pancreatic malignancies were excluded. The final cohort comprised 120 patients. After EST and stone removal, patients were randomized to an intervention group ( n = 60) or a control group ( n = 60) using a sealed envelope approach. In the intervention group, TXA (1 g) and sucralfate (2 g) were directly sprayed onto the wound. All patients were monitored for 14 days. The primary outcome was the occurrence of delayed post-EST bleeding during the observation period. Results: Freedom from delayed bleeding within 14 days was significantly longer in the intervention group than in the control group ( p = 0.023). TXA and sucralfate application reduced the incidence of delayed post-EST bleeding (0% and 8.3%, respectively) and substantial blood loss (1.6% and 16.6%, respectively). Conclusion: Topical TXA and sucralfate application holds promise for preventing delayed post-EST bleeding. Trial registration: This study was registered at ClinicalTrials.gov (NCT06107504).