Efficacy and safety of novel hemostatic gel in endoscopic sphincterotomy or endoscopic papillectomy: A multicenter, randomized controlled clinical trial

Abstract

Background: Endoscopists often experience obstacles with traditional hemostasis using the side-viewing duodenoscope for bleeding after endoscopic sphincterotomy (EST) or endoscopic papillectomy (EP).

Aims: In this randomized controlled trial, we evaluated the efficacy and safety of a novel hemostatic gel for post-EST or post-EP bleeding.

Methods: A randomized trial was conducted from November 2020 to December 2021 at two tertiary centers in South Korea. Patients who experienced bleeding immediately after EST or EP were enrolled in the study, and primary hemostasis was achieved with either the novel hemostatic gel or epinephrine spray.

Results: A total of 84 patients were enrolled in this study, and 41 patients were finally analyzed in each group. Hemostatic gel was significantly superior to epinephrine spray for successful primary hemostasis (100% vs. 85.4%; P = 0.026). ). In terms of delayed bleeding, no significant difference was observed between the hemostatic gel and epinephrine spray (2.4% vs. 7.3%; P = 0.329). The mean procedural time was significantly higher for the hemostatic gel than epinephrine spray (3.23 ± 1.94 vs. 1.76 ± 0.99 min; P < 0.001), and no differences were observed in the adverse events.

Conclusions: The novel hemostatic gel is expected to achieve satisfactory results with easier hemostasis for immediate bleeding after EST or EP. (Registered in Clinical Research Information Service: KCT0005607).

Keywords: Endoscopic papillectomy; Endoscopic sphincterotomy; Hemostatic gel; Post-procedural bleeding; Randomized controlled trial.