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

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

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:
  • Band ligation
Experimental: follow up every 2 weeks
Variceal Band ligation every 2 weeks
Band ligation of OV
Other Names:
  • Band ligation
Experimental: follow up every 3 weeks
Variceal Band ligation every 3 weeks
Band ligation of OV
Other Names:
  • Band ligation
Experimental: follow up every 4 weeks
Variceal Band ligation every 4 weeks
Band ligation of OV
Other Names:
  • Band ligation

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.

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

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.

Clinical Trials on Esophageal Varices

Clinical Trials on Esophageal Variceal Band ligation

3
Subscribe