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

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

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

Study Overview

• Status: Unknown
• Conditions: Bleeding Esophageal Varices
• Intervention / Treatment: Drug: Injection Sclerotherapy; Drug: N-butyl-2-cyanoacrylate

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • Sherief Abd-Elsalam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• cirrhotic patients presented with actively bleeding

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Injection Sclerotherapy; 5% ethano lamine oleate	Drug: Injection Sclerotherapy; 5% ethanolamine oleate group; Other Names: 5% ethanolamine oleate
Active Comparator: N-butyl-2-cyanoacrylate; N-butyl-2-cyanoacrylate injection group	Drug: N-butyl-2-cyanoacrylate; N-butyl-2-cyanoacrylate injection group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with controlled bleeding	The Number of patients with controlled bleeding	6 months

Collaborators and Investigators

• Sponsor: Sherief Abd-Elsalam
• Investigators: Principal Investigator: Mohamed Alsebaey, MD, Gastroenterology; Study Director: Mohamed Abdelraouf, MD, Gastroenterology; Study Director: Sherief Abd-Elsalam, MD, Hepatology and Gastroenterology

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: December 23, 2017
• First Submitted That Met QC Criteria: December 23, 2017
• First Posted (Actual): January 2, 2018

Study Record Updates

• Last Update Posted (Actual): April 24, 2018
• Last Update Submitted That Met QC Criteria: April 20, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Liver Diseases; Esophageal Diseases; Hypertension, Portal; Hemorrhage; Esophageal and Gastric Varices; Gastrointestinal Hemorrhage; Pharmaceutical Solutions; Sclerosing Solutions; Ethanolamine oleate
• Other Study ID Numbers: Active bleeding

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No