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

Jin Ho Choi, In Rae Cho, Sang Hyub Lee, Joo Seong Kim, Namyoung Park, Min Woo Lee, Dong Kee Jang, Woo Hyun Paik, Dong Won Ahn, Ji Kon Ryu, Yong Tae Kim, Eunji Kim, Jaeyoung Lee

Research output: Contribution to journalArticlepeer-review

3 Scopus citations

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.

Original languageEnglish
Pages (from-to)527-533
Number of pages7
JournalDigestive and Liver Disease
Volume55
Issue number4
DOIs
StatePublished - Apr 2023

Keywords

  • Endoscopic papillectomy
  • Endoscopic sphincterotomy
  • Hemostatic gel
  • Post-procedural bleeding
  • Randomized controlled trial

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