RCT of Carvedilol Versus Variceal Band Ligation in the Primary Prophylaxis of Oesophageal Variceal Haemorrhage

February 17, 2010 updated by: Aga Khan University

RCT of Carvedilol vs Variceal Band Ligation in the Primary Prophylaxis of Oesophageal Variceal Haemorrhage

Aim To compare Carvedilol with variceal band ligation in the prevention of first variceal bleed.

End points of trial Primary: Variceal hemorrhage Secondary: Death

Study design

Randomised controlled clinical trial. Results analysed for the above end points on an intention-to-treat basis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients from the Gastroenterology section of the Aga Khan University, Karachi, with liver cirrhosis and on endoscopy having grade II, or larger oesophageal varices and who have not bled previously from varices.

Method All suitable patients will be recruited after informed consent is given. Randomisation of treatment is by sealed envelopes prepared in batches of 20.

Carvedilol This will be administered as a once daily dose of 12.5mg.

Variceal band ligation Endoscopy will be performed ever two weeks until eradication of oesophageal varices. Eradication is achieved when no varices or only grade I varices (varices which are small and flatten on air insufflations in the oesophagus) are present. Subsequent endoscopy sessions will be progressively less frequent, at intervals of 3 months, 6 months and 12 months thereafter. Should varices recur, the protocol for eradication as described above will be re-instituted.

Follow-up This will take place in a dedicated clinic. First visit is six weeks after initiation of treatment and three monthly thereafter. Clinical and laboratory parameters will be obtained at each visit. All patients with alcoholic liver disease will be asked to provide an up-to-date status on drinking. Treatment will cease upon reaching any of these end-points: variceal haemorrhage, death or liver transplantation. Duration of follow-up is defined as time from randomisation to the above end points or to the last follow-up date available.

Study Type

Interventional

Enrollment (Anticipated)

148

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74800
        • Recruiting
        • Aga Khan University Hospital
        • Contact:
        • Principal Investigator:
          • Syed Hasnain A Shah, FRCP
        • Sub-Investigator:
          • Amna Butt, MBBS, FCPS
        • Sub-Investigator:
          • Ambreen Pyarali, MBBS

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with liver cirrhosis and on endoscopy having grade II, or larger oesophageal varices and who have not bled previously from varices.

Exclusion Criteria:

  • Age <18 or > 75 years.
  • Pregnant or lactating patients: patients of childbearing age who are not on contraception.
  • Allergy to Carvedilol.
  • Already on beta blockers or nitrates.
  • Presence of malignancy that will significantly affect survival.
  • Presence of severe systemic illness e.g. cardiorespiratory, active sepsis.
  • Psychiatric disease or learning difficulty that will prevent the granting of informed consent.
  • Presence of obstructive airways disease.

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
Active Comparator: Carvedilol
Each patient will receive Carvedilol 12.5mg QD
Drug: Carvedilol
Carvedilol 12.5mg QD
Other Names:
  • carvida
Active Comparator: Esophageal Variceal Band Ligation
Each patient will undergo for serial esophageal variceal band ligations after 3 weeks of last session till the eradication of varices
Procedure: Esophageal variceal band ligation
Each patient will undergo for variceal band ligation after 3 weeks till the eradication of varices
Other Names:
  • EVBL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Variceal hemorrhage
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
death
Time Frame: one year
one year

Collaborators and Investigators

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

Sponsor

Aga Khan University

Investigators

  • Principal Investigator: Syed hasnain A Shah, MBBS, FRCP, Aga Khan University Hospital, Karachi

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

June 1, 2002

Primary Completion (Anticipated)

February 1, 2011

Study Completion (Anticipated)

July 1, 2011

Study Registration Dates

First Submitted

February 17, 2010

First Submitted That Met QC Criteria

February 17, 2010

First Posted (Estimate)

February 18, 2010

Study Record Updates

Last Update Posted (Estimate)

February 18, 2010

Last Update Submitted That Met QC Criteria

February 17, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCT carvidalol vs EVBL

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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