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Optimal Time for Follow up After Variceal Band Ligation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04602663
Recruitment Status : Recruiting
First Posted : October 26, 2020
Last Update Posted : October 26, 2020
Sponsor:
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

Study Description
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Brief Summary:
Optimal time for follow up after variceal band ligation in cirrhotic patients remains to be determined

Condition or disease Intervention/treatment Phase
Esophageal Varices Device: Esophageal Variceal Band ligation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimal Time for Follow up After Variceal Band Ligation in Cirrhotic Patients: a Randomized Trial
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins

Arms and Interventions
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Arm Intervention/treatment
Experimental: follow up every week
Variceal Band ligation every week.
 Device: Esophageal Variceal Band ligation
Band ligation of OV
Other Name: Band ligation
Experimental: follow up every 2 weeks
Variceal Band ligation every 2 weeks
 Device: Esophageal Variceal Band ligation
Band ligation of OV
Other Name: Band ligation
Experimental: follow up every 3 weeks
Variceal Band ligation every 3 weeks
 Device: Esophageal Variceal Band ligation
Band ligation of OV
Other Name: Band ligation
Experimental: follow up every 4 weeks
Variceal Band ligation every 4 weeks
 Device: Esophageal Variceal Band ligation
Band ligation of OV
Other Name: Band ligation


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with eradicated varices [ Time Frame: 1 year ]
    The total number of patients with eradicated varices


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • cirrhotic portal hypertension with medium or large sized or risky varices or variceal bleeding

Exclusion Criteria:

  • non-cirrhotic portal hypertension
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04602663


Contacts
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Contact: Sherief Abd-Elsalam, MD 00201147773440 sheriefabdelsalam@yahoo.com
Contact: Mohamed Alboraie, MD 0020106445739 sheriefabdelsalam@gmail.com

Locations
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Egypt
Sherief Abd-Elsalam Recruiting
Tanta, Egypt
Contact: Sherief Abd-elsalam, lecturer    00201000040794    Sherif_tropical@yahoo.com   
Sponsors and Collaborators
Tanta University
Investigators
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Principal Investigator: Mohamed Alboraie, MD Al-Azhar University
Principal Investigator: Ahmed Maher, MD Cairo University
More Information
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Responsible Party: Sherief Abd-Elsalam, Ass. Prof. Tropical Medicine, Tanta University
ClinicalTrials.gov Identifier: NCT04602663    
Other Study ID Numbers: VARICES
First Posted: October 26, 2020    Key Record Dates
Last Update Posted: October 26, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Esophageal and Gastric Varices
Esophageal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Hypertension, Portal
Liver Diseases