- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03388125
Endoscopic Injection Sclerotherapy Versus N-butyl-2-cyanoacrylate Injection
April 20, 2018 updated by: Sherief Abd-Elsalam
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tanta, Egypt
- Sherief Abd-Elsalam
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Injection Sclerotherapy
5% ethano lamine oleate
|
5% ethanolamine oleate group
Other Names:
|
Active Comparator: N-butyl-2-cyanoacrylate
N-butyl-2-cyanoacrylate injection group
|
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
Time Frame: 6 months
|
The Number of patients with controlled bleeding
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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