Carvedilol Versus Endoscopic Band Ligation for Primary Prophylaxis of Oesophageal Variceal Bleeding

August 1, 2020 updated by: Sherief Abd-Elsalam

Randomized Controlled Trial of Carvedilol Versus Endoscopic Band Ligation for Primary Prophylaxis of Oesophageal Variceal Bleeding in Cirrhotic Patients With Arterial Hypertension

Carvedilol versus endoscopic band ligation for primary prophylaxis of oesophageal variceal bleeding in cirrhotic patients with arterial hypertension

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A Randomized controlled trial of carvedilol versus endoscopic band ligation for primary prophylaxis of oesophageal variceal bleeding in cirrhotic patients with arterial hypertension

Study Type

Interventional

Enrollment (Anticipated)

306

Phase

  • Phase 2
  • 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 Contact

Study Locations

  • Egypt
      • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • • Aged >18 years

    • Cirrhotic patients with arterial hypertension
    • Endoscopic evidence of medium/large-sized esophageal varices

Exclusion Criteria:

  • • History of variceal bleeding or previous primary prevention of varices.

    • Portal vein thrombosis or previous porto-systemic shunts as TIPS.
    • Patients on drugs affecting portal pressure (beta blockers, nitrates).
    • Advanced cardiovascular disease including acute myocardial infarction, atrio-ventricular block, congestive heart failure, chronic peripheral ischemia, severe bradycardia.
    • Patients with severe respiratory diseases (COPD, bronchial asthma).
    • Uncontrolled diabetes mellitus
    • Renal impairment
    • Hepatocellular carcinoma
    • Allergy to carvedilol
    • Pregnancy or lactation

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: carvedilol
Carvedilol
Drug: Carvedilol
Carvedilol
Other Names:
  • carvid
Active Comparator: Band Ligation
Procedure: Endoscopic band ligation
Endoscopic band ligation
Other Names:
  • band ligation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with the first variceal bleeding within 1 year
Time Frame: 1 year
The number of patients with the first variceal bleeding within 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sherief Abd-Elsalam

Investigators

  • Study Director: Asem Elfert, Prof, Tanta university - faculty of medicine
  • Principal Investigator: Nabila Abd El-Nasser Abd El-Wahed El-Gazzar, ass. lect, Tanta University Faculty of medicine

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, 2018

Primary Completion (Anticipated)

December 1, 2030

Study Completion (Anticipated)

December 10, 2030

Study Registration Dates

First Submitted

August 1, 2020

First Submitted That Met QC Criteria

August 1, 2020

First Posted (Actual)

August 5, 2020

Study Record Updates

Last Update Posted (Actual)

August 5, 2020

Last Update Submitted That Met QC Criteria

August 1, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • nabeela protocol

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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