Efficacy and Safety of a Self-Assembling Peptide Hydrogel in Managing Endoscopic Sphincterotomy-related Bleeding: A Prospective Cohort Study

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Aims Endoscopic sphincterotomy (EST) is a fundamental procedure in endoscopic retrograde cholangiopancreatography, but it carries a risk of bleeding. The aim of this study was to evaluate the efficacy and safety of using a self-assembling peptide hydrogel (SAPH) to control bleeding associated with EST. Methods A prospective cohort study was conducted across three hospitals in Japan. Patients who underwent EST were divided into two groups: those with EST-related hemorrhage treated with SAPH (SAPH group) and those without EST-related hemorrhage (control group). During the study period, the primary treatment strategy for EST-related bleeding was SAPH application. The primary endpoint was the incidence of delayed bleeding. Secondary endpoints included the clinical success of SAPH in achieving initial hemostasis and the rate of adverse events such as pancreatitis and cholangitis. Results Of the 254 patients analyzed, 27 were assigned to the SAPH group and 227 to the control group. There were no significant differences in patient background (platelet count, cirrhosis, hemodialysis, antithrombotic medications, peripapillary diverticulum, duodenal stenosis, primary disease) other than PT-INR. Regarding procedure-related background factors, procedure time was longer in the SAPH group, but there were no significant differences in difficult bile duct cannulation, concurrent duodenal papillary balloon dilatation, or procedures performed after EST. The SAPH group achieved successful hemostasis with SAPH alone in 96.3% (26/27) of cases. One case with spurting bleeding did not achieve hemostasis with SAPH alone; however, SAPH application moderated the bleeding, and subsequent SEMS placement achieved complete hemostasis. No cases of delayed bleeding occurred in the SAPH group, whereas the control group had a delayed bleeding incidence of 1.76% (4/227). Adverse events showed no significant difference between the groups. Conclusions SAPH is a simple, effective, and safe hemostatic tool, which could be considered as an initial treatment choice for EST-related hemorrhage. Although the reduction in delayed bleeding was not statistically significant, SAPH may offer a promising solution to manage and prevent bleeding complications in EST procedures. Publication History Article published online: 27 March 2025 © 2025. European Society of Gastrointestinal Endoscopy. All rights reserved. Georg Thieme Verlag KG Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany

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