Back to resultsEndoscopic Injection Sclerotherapy Versus N-butyl-2-cyanoacrylate Injection
Primary Purpose
Bleeding Esophageal Varices
Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Injection Sclerotherapy
N-butyl-2-cyanoacrylate
Sponsored by
About this trial
This is an interventional treatment trial for Bleeding Esophageal Varices
Eligibility Criteria
Inclusion Criteria:
- cirrhotic patients presented with actively bleeding
Exclusion Criteria:
- other sources of UGIB than esophageal varices, hepatic encephalopathy or hepatocellular carcinoma (HCC)
Sites / Locations
- Sherief Abd-Elsalam
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Injection Sclerotherapy
N-butyl-2-cyanoacrylate
Arm Description
5% ethano lamine oleate
N-butyl-2-cyanoacrylate injection group
Outcomes
Primary Outcome Measures
Number of patients with controlled bleeding
The Number of patients with controlled bleeding
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03388125
Brief Title
Endoscopic Injection Sclerotherapy Versus N-butyl-2-cyanoacrylate Injection
Official Title
Endoscopic Injection Sclerotherapy Versus N-butyl-2-cyanoacrylate Injection in the Management of Actively Bleeding Esophageal Varices
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
August 1, 2017 (Actual)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sherief Abd-Elsalam
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Endoscopic Injection Sclerotherapy vs N-butyl-2-cyanoacrylate Injection
Detailed Description
Endoscopic Injection Sclerotherapy versus N-butyl-2-cyanoacrylate Injection in the Management of Actively Bleeding Esophageal Varices
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding Esophageal Varices
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
113 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Injection Sclerotherapy
Arm Type
Active Comparator
Arm Description
5% ethano lamine oleate
Arm Title
N-butyl-2-cyanoacrylate
Arm Type
Active Comparator
Arm Description
N-butyl-2-cyanoacrylate injection group
Intervention Type
Drug
Intervention Name(s)
Injection Sclerotherapy
Other Intervention Name(s)
5% ethanolamine oleate
Intervention Description
5% ethanolamine oleate group
Intervention Type
Drug
Intervention Name(s)
N-butyl-2-cyanoacrylate
Intervention Description
N-butyl-2-cyanoacrylate injection group
Primary Outcome Measure Information:
Title
Number of patients with controlled bleeding
Description
The Number of patients with controlled bleeding
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
cirrhotic patients presented with actively bleeding
Exclusion Criteria:
other sources of UGIB than esophageal varices, hepatic encephalopathy or hepatocellular carcinoma (HCC)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Alsebaey, MD
Organizational Affiliation
Gastroenterology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed Abdelraouf, MD
Organizational Affiliation
Gastroenterology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sherief Abd-Elsalam, MD
Organizational Affiliation
Hepatology and Gastroenterology
Official's Role
Study Director
Facility Information:
Facility Name
Sherief Abd-Elsalam
City
Tanta
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30717684
Citation
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.
Results Reference
derived
Learn more about this trial
Endoscopic Injection Sclerotherapy Versus N-butyl-2-cyanoacrylate Injection
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