System Maintenance Notice

Please note that maintenance work is scheduled between 4 AM and 5 AM - CET. During this time, you may experience reduced performance. Thanks for your patience.

Publications

Journal Article Epublish

PubMed: 42713139 DOI: 10.1055/a-2933-9485

Prevention of Delayed Bleeding after Endoscopic Resection using Gel Hemostatic Powder: A Multicentric Open-lapel Prospective Study.

Endosc Int Open 14:a29339485

Authors: Julia C Rodriguez, Pierre H Deprez, Raf Bisschops, Pieter Dewint, Pierre Eisendrath, Christophe Snauwaert, Dominiek De Wulf, Philippe Leclercq, Jacques Deviere, Vincent Huberty, Ana Maria Bucalau, Mariana Figueiredo Ferreira, Sohaib Ouazzani, Marianna Arvanitaki, Arnaud Lemmers

Affiliations

  • Department of Gastroenterology, Hepatopancreatology, and Digestive OncologyErasme Hospital, Hôpital Universitaire de Bruxelles (HUB), Université Libre de Bruxelles (ULB)BrusselsBrusselsBelgium.
  • Department of HepatogastroenterologyCliniques Universitaires Saint-Luc, Université Catholique de LouvainBruxellesBruxellesBelgium.
  • Department of Gastroenterology and HepatologyUniversity Hospital LeuvenLeuvenBelgium.
  • Department of Gastroenterology and HepatologyAZ Maria MiddelaresSint-NiklaasFlandersBelgium.
  • Department of Gastroenterology, Hepatopancreatology, and Digestive OncologyCHU Saint Pierre, Université Libre de BruxellesBrusselsBelgium.
  • Department of Hepatology and GastroenterologySint-Jan Brugge General HospitalBrugesFlandersBelgium.
  • Department of Gastroenterology and HepatologyAZ DeltaRoeselareFlandersBelgium.
  • Department of Gastroenterology, Hepatopancreatology, and Digestive OncologyErasme Hospital, Hôpital Universitaire de Bruxelles (HUB), Université Libre de Bruxelles (ULB)BrusselsBrusselsBelgium. Department of Gastroenterology, Hepatopancreatology, and Digestive OncologyCHU Saint Pierre, Université Libre de BruxellesBrusselsBelgium.

Abstract

Background Delayed bleeding (DB) after endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) remains a significant clinical problem. This study aimed to evaluate the safety and efficacy of a new gel hemostatic powder (GHP) for the prevention of DB in high-risk patients. Methods A prospective, multicentric, open-label study was conducted at seven Belgian hospitals from 2023 to 2024 in patients undergoing EMR or ESD for lesions over 20 mm with high risk of DB (either anticoagulant or P2Y12RA treated, or undergoing duodenal EMR). The Nexpowder GHP preventive spray was applied to the resected area at the end of the procedure. The primary outcome was the rate of DB within 4 weeks post-procedure. Secondary outcomes included safety, procedure duration, post-procedural pain, and incidence of adverse events. Results Fifty patients were enrolled in the study and treated with endoscopic resection followed by GHP application. The observed DB rate was 22% (11/50), higher than the literature-reported rate of 16%. The hypothesized reduction in DB below 5% was not achieved ( p = 0.2472). DB was most common in rectal ESD ( n = 3/5; 60%) and duodenal EMR ( n = 6/20; 30%). DB typically occurred within the first 10 days post-procedure (median onset 7d). On univariate analysis, the only factor associated with DB risk was lesion size ( p = 0.042). No adverse events related to the use of the GHP were reported. Conclusion In this prospective study, GHP demonstrated limited efficacy for the prevention of DB in high-risk patients, with a 22% observed DB rate. Lesion size and location were key predictors of DB.

MeSH

Safety, Hemorrhage, Powders, Hemostatics, Drug-Related Side Effects And Adverse Reactions, Endoscopic Mucosal Resection, Prospective Studies