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Randomised controlled trial of carvedilol versus variceal band ligation in the primary prophylaxis of oesophageal variceal haemorrhage

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN26269039
Enrollment
152
Registered
2007-07-05
Start date
2000-02-14
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis and portal hypertension Digestive System Other diseases of liver

Interventions

1. Carvedilol starting at 6.25 mg per day for a week, to increase to 12.5 per day thereafter if tolerated 2. Variceal band ligation to be performed every two weeks until variceal eradication The foll

Sponsors

University of Edinburgh (UK)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Liver cirrhosis and the presence of Grade II or larger oesophageal varices.

Exclusion criteria

Exclusion criteria: 1. Aged less than 18 or greater than 75 2. Medication: vasoactive drugs such as beta blockers or nitrates 3. Advanced cardiopulmonary disease 4. Malignancy with prognosis that will affect study outcome 5. Allergy to carvedilol 6. Patients with obstructive airways disease

Design outcomes

Primary

MeasureTime frame
The first variceal bleed. The outcomes were measured for the entire follow up period and also at 6, 12, and 24 months.

Secondary

MeasureTime frame
1. Overall mortality 2. Variceal bleeding related mortality 3. Adverse events leading to treatment discontinuation The outcomes were measured for the entire follow up period and also at 6, 12, and 24 months. Bleeding induced mortality was defined as death within 6 weeks of the index variceal bleed.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026