Endoscopic Injection Sclerotherapy Versus N-butyl-2-cyanoacrylate Injection

NCT03388125 — Phase 3, Unknown, 113 participants, Sherief Abd-Elsalam

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Endoscopic Injection Sclerotherapy Versus N-butyl-2-cyanoacrylate Injection in the Management of Actively Bleeding Esophageal Varices

Registry	NCT03388125
Status	Unknown
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	113 (Actual)
Sponsor	Sherief Abd-Elsalam (Other)
Conditions	Bleeding Esophageal Varices
Interventions	Injection Sclerotherapy, N-butyl-2-cyanoacrylate (Drug)
Dates	start 2016-01-01, primary completion 2017-08-01, completion 2022-12-01 (estimated), first posted 2018-01-02, last updated 2018-04-24
Locations	1 site in Egypt

-Summary

Endoscopic Injection Sclerotherapy vs N-butyl-2-cyanoacrylate Injection

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+Detailed description

Endoscopic Injection Sclerotherapy versus N-butyl-2-cyanoacrylate Injection in the Management of Actively Bleeding Esophageal Varices

+Arms and interventions

Arm	Type	Interventions	Description
Injection Sclerotherapy	Active comparator	Drug: Injection Sclerotherapy	5% ethano lamine oleate
N-butyl-2-cyanoacrylate	Active comparator	Drug: N-butyl-2-cyanoacrylate	N-butyl-2-cyanoacrylate injection group

Injection Sclerotherapy (Drug), also known as 5% ethanolamine oleate: 5% ethanolamine oleate group
N-butyl-2-cyanoacrylate (Drug): N-butyl-2-cyanoacrylate injection group

+Outcome measures

Primary outcomes

Number of patients with controlled bleeding [6 months]: The Number of patients with controlled bleeding

+Eligibility

Sex: All

Inclusion Criteria:

* cirrhotic patients presented with actively bleeding

Exclusion Criteria:

* other sources of UGIB than esophageal varices, hepatic encephalopathy or hepatocellular carcinoma (HCC)

+Locations (1)

Facility	City	Country	Status
Sherief Abd-Elsalam	Tanta	Egypt

+Publications

Results publication: Elsebaey MA, Tawfik MA, Ezzat S, Selim A, Elashry H, Abd-Elsalam S. Endoscopic injection sclerotherapy versus N-Butyl-2 Cyanoacrylate injection in the management of actively bleeding esophageal varices: a randomized controlled trial. BMC Gastroenterol. 2019 Feb 4;19(1):23. doi: 10.1186/s12876-019-0940-1. PMID 30717684

+Investigators

Mohamed Alsebaey, MD, Principal investigator, Gastroenterology
Mohamed Abdelraouf, MD, Study director, Gastroenterology
Sherief Abd-Elsalam, MD, Study director, Hepatology and Gastroenterology