Back to resultsOptimal Time for Follow up After Variceal Band Ligation
Primary Purpose
Esophageal Varices
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Esophageal Variceal Band ligation
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Varices
Eligibility Criteria
Inclusion Criteria:
- cirrhotic portal hypertension with medium or large sized or risky varices or variceal bleeding
Exclusion Criteria:
- non-cirrhotic portal hypertension
Sites / Locations
- Sherief Abd-ElsalamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
follow up every week
follow up every 2 weeks
follow up every 3 weeks
follow up every 4 weeks
Arm Description
Variceal Band ligation every week.
Variceal Band ligation every 2 weeks
Variceal Band ligation every 3 weeks
Variceal Band ligation every 4 weeks
Outcomes
Primary Outcome Measures
Number of patients with eradicated varices
The total number of patients with eradicated varices
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04602663
Brief Title
Optimal Time for Follow up After Variceal Band Ligation
Official Title
Optimal Time for Follow up After Variceal Band Ligation in Cirrhotic Patients: a Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Optimal time for follow up after variceal band ligation in cirrhotic patients remains to be determined
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Varices
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
follow up every week
Arm Type
Experimental
Arm Description
Variceal Band ligation every week.
Arm Title
follow up every 2 weeks
Arm Type
Experimental
Arm Description
Variceal Band ligation every 2 weeks
Arm Title
follow up every 3 weeks
Arm Type
Experimental
Arm Description
Variceal Band ligation every 3 weeks
Arm Title
follow up every 4 weeks
Arm Type
Experimental
Arm Description
Variceal Band ligation every 4 weeks
Intervention Type
Device
Intervention Name(s)
Esophageal Variceal Band ligation
Other Intervention Name(s)
Band ligation
Intervention Description
Band ligation of OV
Primary Outcome Measure Information:
Title
Number of patients with eradicated varices
Description
The total number of patients with eradicated varices
Time Frame
1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
cirrhotic portal hypertension with medium or large sized or risky varices or variceal bleeding
Exclusion Criteria:
non-cirrhotic portal hypertension
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief Abd-Elsalam, MD
Phone
00201147773440
Email
sheriefabdelsalam@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Alboraie, MD
Phone
0020106445739
Email
sheriefabdelsalam@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Alboraie, MD
Organizational Affiliation
Al-Azhar University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahmed Maher, MD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sherief Abd-Elsalam
City
Tanta
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherief Abd-elsalam, lecturer
Phone
00201000040794
Email
Sherif_tropical@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Optimal Time for Follow up After Variceal Band Ligation
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