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Randomized Controlled Trial
. 2019 Feb 4;19(1):23.
doi: 10.1186/s12876-019-0940-1.

Endoscopic injection sclerotherapy versus N-Butyl-2 Cyanoacrylate injection in the management of actively bleeding esophageal varices: a randomized controlled trial

Mohamed A Elsebaey  1 , Mohamed A Tawfik  2 , Sherif Ezzat  1 , Amal Selim  1 , Heba Elashry  3 , Sherief Abd-Elsalam  3
Affiliations
Randomized Controlled Trial

Endoscopic injection sclerotherapy versus N-Butyl-2 Cyanoacrylate injection in the management of actively bleeding esophageal varices: a randomized controlled trial

Mohamed A Elsebaey et al. BMC Gastroenterol. .

Abstract

Background: The management of acute esophageal variceal bleeding remains a clinical challenge. Band ligation is the main therapeutic option, but it may be technically difficult to perform in active bleeders. This may necessitate an alternative therapy for this group of patients. This study was conducted to assess the safety and efficacy of sclerotherapy versus cyanoacrylate injection for management of actively bleeding esophageal varices in cirrhotic patients.

Methods: This prospective study included 113 cirrhotic patients with actively bleeding esophageal varices. They were randomly treated by endoscopic sclerotherapy or cyanoacrylate injection as banding was not suitable for those patients due to profuse bleeding making unclear endoscopic visual field. Primary outcome was incidence of active bleeding control and secondary outcomes were incidence of six weeks rebleeding, complications, and mortality among the studied patients.

Results: Initial bleeding control was significantly higher in cyanoacrylate versus sclerotherapy groups (98.25, 83.93% respectively, P = 0.007). No significant differences between sclerotherapy and cyanoacrylate groups regarding rebleeding (26.79, 19.30% respectively, P = 0.344), complications, hospital stay or mortality rate were observed.

Conclusions: Based on this single-center prospective study, both of these therapies appear to have relatively favorable outcomes, although cyanoacrylate injection may be superior to sclerotherapy for initial control of active bleeding.

Trial registration: [ClinicalTrials.gov Identifier: NCT03388125 ]-Date of registration: January 2, 2018 "Retrospectively registered".

Keywords: Cyanoacrylate injection; Esophageal varices; iInjection sclerotherapy.

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Conflict of interest statement

Competing interest

The authors declare that they have no competing interests.

Ethics approval and consent to participate

The study protocol was done in accordance to the ethical guidelines of the 1975 Helsinki Declaration. The study protocol was approved by the Research Ethics Committee of Quality Assurance Unit of Faculty of Medicine, Tanta University with approval code 1734/03/13. A written informed consent was obtained from all included patients in this study. Our study adheres to CONSORT guidelines.

Consent for publication

Not applicable.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
The Kaplan-Meier curve of rebleedings
See this image and copyright information in PMC

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