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

Phase 4

• Conditions: Portal Hypertension
• Interventions: Drug: Carvedilol; Procedure: Esophageal variceal band ligation

• Registration Number: NCT01070641
• Lead Sponsor: Aga Khan University

Brief 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.

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 Timeline

• Study Start: 2002-06
• Status Verified: 2010-02
• Study First Submitted: 2010-02-17
• Study First Submitted QC: 2010-02-17
• Last Update Submitted: 2010-02-17
• Study First Posted: 2010-02-18
• Last Update Posted: 2010-02-18
• Primary Completion: 2011-02
• Study Completion: 2011-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 148

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carvedilol	Carvedilol	Each patient will receive Carvedilol 12.5mg QD
Esophageal Variceal Band Ligation	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

Primary Outcome Measures

Name	Time	Method
Variceal hemorrhage	one year

Secondary Outcome Measures

Name	Time	Method
death	one year

Trial Locations

Locations (1)

Aga Khan University Hospital; 🇵🇰 Karachi, Sindh, Pakistan