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
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Article info
Publication history
Published online: February 01, 2023
Accepted:
January 22,
2023
Received:
July 6,
2022
Identification
Copyright
© 2023 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.
