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Randomized Controlled Trial
. 2019 May;68(5):844-853.
doi: 10.1136/gutjnl-2017-314653. Epub 2018 May 5.

Early application of haemostatic powder added to standard management for oesophagogastric variceal bleeding: a randomised trial

Mostafa Ibrahim  1   2 , Ahmed El-Mikkawy  2 , Mohamed Abdel Hamid  2 , Haitham Abdalla  2 , Arnaud Lemmers  1 , Ibrahim Mostafa  2 , Jacques Devière  1
Affiliations
Randomized Controlled Trial

Early application of haemostatic powder added to standard management for oesophagogastric variceal bleeding: a randomised trial

Mostafa Ibrahim et al. Gut. 2019 May.

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.

Keywords: bleeding; cirrhosis; oesophageal varices; portal hypertension.

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Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Flow chart of the study.
Figure 2
Figure 2
Overview of both groups in the first 5 days.
Figure 3
Figure 3
Kaplan-Meier survival curves at 5, 15 and 30 days for patients treated with Hemospray plus pharmacotherapy and endotherapy (Hemospray group) or with pharmacotherapy and endotherapy alone (pharmacotherapy–endotherapy group).
Figure 4
Figure 4
Flow chart summarising rebleeding in line with clinical and endoscopic haemostasis.
Figure 5
Figure 5
Flow chart summarising mortality in line with clinical and endoscopic haemostasis.
See this image and copyright information in PMC

Comment in

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