Prospective observational study of a novel self-assembling peptide hemostatic gel for initial hemostasis in endoscopic sphincterotomy-related hemorrhage

Aims Bleeding is recognized as one of the most commonly encountered adverse events associated with endoscopic sphincterotomy (EST). Although various techniques for endoscopic hemostasis have been reported, the treatment choice is left to the endoscopist. A novel self-assembling and fully synthetic hydrogel peptide (hemostatic gel) is currently developed as a hemostatic agent. This study aimed to evaluate the feasibility and effectiveness of the application of hemostatic gel to EST-related hemorrhage.

Methods Between September 2021 and August 2023, 202 patients who were scheduled to undergo EST were prospectively enrolled in this study. Hemostatic gel was used only when bleeding occurred during EST. Patients without EST-related hemorrhage were assigned to the control group, and patients with EST-related hemorrhage were assigned to the hemostatic gel group. Patients’ characteristics and clinical course were compared between the two groups. EST-related bleeding was defined as bleeding immediately after EST and the procedure could not be continued because of poor visibility by blood, or bleeding for more than 5 min caused by device contact during the same session as the EST.

Results EST was performed in 188 of 202 patients, and EST-related bleeding occurred in 20 patients using hemostatic gel, with a median age of 76.0 years in the control group and 76.5 years in the hemostatic gel group. 45 patients in the control group and 4 patients in the hemostatic gel group receiving antithrombotic therapy were included in this study. There were 114 cases of benign diseases and 54 cases of malignant diseases in the control group, while there were 9 cases of benign diseases and 11 cases of malignant disease in the hemostatic gel group. The details of the procedure [EST only/stone removal/plastic stent placement/self-expandable metallic stent (SEMS) placement] were 4/86/54/24 cases in the control group and 1/5/10/4 cases in the hemostatic gel group. There were 50 cases of parapapillary diverticulum in the control group and 8 cases in the hemostatic gel group. Hemostasis was achieved using hemostatic gel alone in all but one of the 20 patients in the hemostatic gel group without additional hemostatic treatment. One case in which hemostasis was not achieved with hemostatic gel was of spurting bleeding, whereas hemostasis was confirmed by SEMS placement. The incidence of adverse events was 10.1% in the control group and 10.0% in the hemostatic gel group. Adverse events in each group (control/hemostatic gel) were pancreatitis (6/2), cholangitis (6/0), post-procedural bleeding (3/0), and others (2/0). There were no statistically significant differences in patients’ characteristics, procedures, and rates of adverse events.

Conclusions The application of hemostatic gel for EST-related bleeding is a feasible and safe hemostatic method. Hemostatic gel may be an option for initial hemostasis for EST-related bleeding. [1] [2]

Publication History

Article published online:
15 April 2024

• References

• 1 Ishida Y, Tsuchiya N, Koga T. et al. A novel self-assembling peptide hemostatic gel as an option for initial hemostasis in endoscopic sphincterotomy-related hemorrhage: a case series. Clin J Gastroenterol 2022; 15: 1210-1215
• 2 Uba Y, Ogura T, Ueno S. et al. Comparison of endoscopic hemostasis for endoscopic sphincterotomy bleeding between a novel self-assembling peptide and conventional technique. J Clin Med Res 2022; 12: 79