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

• Status: Unknown status
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aga Khan University
• Treatments: Carvedilol

Criteria

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.