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Original article
Early application of haemostatic powder added to standard management for oesophagogastric variceal bleeding: a randomised trial
  1. Mostafa Ibrahim1,2,
  2. Ahmed El-Mikkawy2,
  3. Mohamed Abdel Hamid2,
  4. Haitham Abdalla2,
  5. Arnaud Lemmers1,
  6. Ibrahim Mostafa2,
  7. Jacques Devière1
  1. 1 Department of Gastroenterology, Hepatopancreatology and Digestive Oncology, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium
  2. 2 Theodor Bilharz Research Institute, Department of Gastroenterology and Hepatology, Cairo, Egypt
  1. Correspondence to Dr Mostafa Ibrahim, Department of Gastroenterology, Erasme Hospital, University Libre de Bruxelles, Brussels 1070, Belgium; mostafa.ibrahim{at}webgit.net

Abstract

Background Acute variceal bleeding (AVB) requires early therapeutic management by experienced endoscopists that often poses logistical challenges for hospitals. We assessed a different management concept with early application of haemostatic powder—which does not require high endoscopic expertise—added to conventional management in a randomised trial.

Methods Cirrhotic patients with AVB received standard medical therapy and were randomised to either immediate endoscopy with haemostatic powder application within 2 hours of admission, followed by early elective endoscopy on the next day, that is, within 12–24 hours of admission for definitive treatment (study group) or to early elective endoscopy only (control group). In both groups, failures to achieve clinical haemostasis until the time of early elective endoscopy underwent rescue endoscopy with attempted conventional haemostasis. Primary outcome was endoscopic haemostasis at the elective endoscopy.

Results Of 86 randomised patients with AVB, 5/43 in the study group required rescue endoscopy for failure of controlling spurting bleeding (n=4) after powder application or for early bleeding recurrence in one patient who died before repeating rescue endoscopy. In the control group, 13/43 patients required rescue endoscopic haemostasis for failure of clinical haemostasis (12%vs30%, p=0.034). In the remaining patients, early elective endoscopic haemostasis was achieved in all 38 patients in the study group, while all remaining 30 patients in the control group had fresh gastric blood or (10%) spurting bleeding at early elective endoscopy with successful haemostasis in all of them. Six-week survival was significantly improved in the study group (7%vs30%, p=0.006).

Conclusion The new concept of immediate powder application improves early clinical and endoscopic haemostasis. This simplified endoscopic approach may have an impact on early and 6-week survival.

Trial registration number NCT03061604.

  • bleeding
  • portal hypertension
  • oesophageal varices
  • cirrhosis

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Contributors MI was responsible for the study design, acquisition of data, analysis and interpretation of data, drafting of the manuscript, technical support and material support. AE-M, HA, AL and MAH were responsible for acquisition of data and technical support. IM was responsible for the study supervision. JD was responsible for study design, interpretation of data, statistical analysis, study supervision and final revision of the manuscript.

  • Funding This study was funded in part by Cook Medical(10.13039/100010479), Educational Grant and by Erasme Hospital (as an investigator initiated study), ULB, Brussels, Belgium and by the Michel Cremer Foundation, Brussels, Belgium

  • Competing interests The study is an investigator-initiated study, MI received an educational grant from Cook Medical. The Hemospray kits were provided from Cook Medical within the educational grant. Disclosure forms provided by the authors are available with the full text of this article.

  • Patient consent Obtained

  • Ethics approval Institutional review board (IRB) of Erasme hospital ,Université libre de Bruxelles (ULB) and Theodor Bilharz Research Institute IRB. Medical ethical committees of both participating centres

  • Provenance and peer review Not commissioned; externally peer reviewed.