Effect of a self-assembling peptide hydrogel on delayed bleeding following endoscopic sphincterotomy: Prospective pilot cohort study

Abstract Endoscopic sphincterotomy (EST) is important in endoscopic retrograde cholangiopancreatography, but bleeding remains its common complication. This pilot study evaluated the efficacy and safety of a self-assembling peptide hydrogel (SAPH; PuraStat) in managing EST-related hemorrhage. A prospective cohort study was conducted from June 2023 to March 2024 at three hospitals in Japan, enrolling patients undergoing EST. Patients were divided into SAPH (received SAPH for EST-related bleeding) and control groups (patients without EST-related hemorrhage); primary endpoint was incidence of delayed bleeding. Of the 254 patients analyzed, 27 were in the SAPH group and 227 in the control group. Background factors related to bleeding were aligned using propensity score matching (PSM). Incidence of EST-related bleeding was 10.6% (27/254). In the SAPH group, 26 of 27 patients (96.3%) achieved successful hemostasis using SAPH alone. Although no delayed bleeding occurred in this group, it occurred in four patients in the control group (1.57%, 4/254). Other adverse events showed no significant difference between the groups. Results were similar to those after PSM and in the subgroup analysis excluding those with self-expandable metallic stent placement. SAPH is a simple, effective, and safe hemostatic option for treating EST-related hemorrhage and may be a promising first-line approach. This pilot study did not demonstrate a significant reduction in delayed bleeding, but absence of delayed bleeding in the SAPH group is noteworthy and suggests a potential preventive benefit. Thus, larger randomized controlled trials are warranted to validate these preliminary findings.