- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04602663
Optimal Time for Follow up After Variceal Band Ligation
October 20, 2020 updated by: Sherief Abd-Elsalam, Tanta University
Optimal Time for Follow up After Variceal Band Ligation in Cirrhotic Patients: a Randomized Trial
Optimal time for follow up after variceal band ligation in cirrhotic patients remains to be determined
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Optimal time for follow up after variceal band ligation in cirrhotic patients remains to be determined.
So, we designed this trial to answer this question.
Study Type
Interventional
Enrollment (Anticipated)
400
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mohamed Alboraie, MD
- Phone Number: 0020106445739
- Email: sheriefabdelsalam@gmail.com
Study Locations
-
-
-
Tanta, Egypt
- Recruiting
- 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 portal hypertension with medium or large sized or risky varices or variceal bleeding
Exclusion Criteria:
- non-cirrhotic portal hypertension
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 |
---|---|
Experimental: follow up every week
Variceal Band ligation every week.
|
Band ligation of OV
Other Names:
|
Experimental: follow up every 2 weeks
Variceal Band ligation every 2 weeks
|
Band ligation of OV
Other Names:
|
Experimental: follow up every 3 weeks
Variceal Band ligation every 3 weeks
|
Band ligation of OV
Other Names:
|
Experimental: follow up every 4 weeks
Variceal Band ligation every 4 weeks
|
Band ligation of OV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with eradicated varices
Time Frame: 1 year
|
The total number of patients with eradicated varices
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mohamed Alboraie, MD, Al-Azhar University
- Principal Investigator: Ahmed Maher, MD, Cairo University
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)
October 1, 2020
Primary Completion (Anticipated)
December 1, 2021
Study Completion (Anticipated)
December 31, 2021
Study Registration Dates
First Submitted
October 20, 2020
First Submitted That Met QC Criteria
October 20, 2020
First Posted (Actual)
October 26, 2020
Study Record Updates
Last Update Posted (Actual)
October 26, 2020
Last Update Submitted That Met QC Criteria
October 20, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VARICES
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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