Treatment of Postsphincterotomy Bleeding With a Novel Self-assembling Peptide Hemostatic Gel

Aims Bleeding following endoscopic sphincterotomy (ES) is among the most common complications of endoscopic retrograde cholangiopancreatography (ERCP). Significant bleeding manifested by melena or hematochezia occurs in 2-5% of procedures. Common endoscopic hemostatic methods include injection of diluted adrenaline, application of hemoclips, and coagulation techniques. Our objective was to assess the safety and efficacy of the a novel self-assembling peptide hemostatic gel in the treatment of acute and delayed bleeding after endoscopic sphincterotomy or precut.

Methods From August 2022 to August 2023, a novel self-assembling peptide hemostatic gel was applied to all consecutive patients in our center who underwent endoscopic sphincterotomy or precut (intervention group). We compared the occurrence of significant bleeding defined by presence of melena, hematemesis, or hematochezia with a historic cohort from the period June 2021 to June 2022 when a novel hemostatic peptide gel was not available (control group). Other outcomes measured included post-ERCP pancreatitis and cholangitis, the number of urgent gastroscopies, and recurrence of bleeding. Data were processed using logistic regression models.

Results In the intervention group, 102 ES and 21 precuts were performed (83% and 17%) in a total of 117 patients, while in the control group, 125 ES and 19 precuts were performed (87% and 13%) in a total of 140 patients. The groups did not differ in average age (66.6+- 16.2; 70.6+- 15.2), gender distribution (M/F 55/85; 50/76), or etiology. Post-ERCP bleeding in the intervention group was significantly less frequent compared to the control group, (3 patients (2.4%) vs. 9 patients (6.4%); OR 0.15; p=0.031). Urgent gastroscopy for overt bleeding after ERCP was performed in 2 patients in the intervention group and 7 in the control group. No recurrences of bleeding were observed. The incidence of post-ERCP pancreatitis and cholangitis did not significantly differ in both groups (p=0.473 and p=0.411).

Conclusions The use of the a novel self-assembling peptide hemostatic gel appears to be an easy, safe, and effective method for treating bleeding after ES. Additional advantages include the transparency of the gel, which does not impede the continuation of the procedure, and the possibility of combination with other hemostatic methods. Considering cost-benefit effectiveness, it is advisable to consider the application in patients with risk factors for bleeding after ES. [1] [2] [3]

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. Clinical Journal of Gastroenterology 2022; 15: 1210-1215
• 2 Ferreira LE, Baron TH.. Post-sphincterotomy bleeding: who, what, when, and how. American Journal of Gastroenterology 2007; 102: 850-2858
• 3 Lesmana CRA, Sandra S, Paramitha MS. et al. Endoscopic management using novel haemostatic agents for immediate bleeding during endoscopic retrograde cholangio pancreatography. Canadian Journal of Gastroenterology and Hepatology 2023 Article ID 5212580