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

Completed

• Conditions: Cirrhosis and portal hypertension; Digestive System; Other diseases of liver

• Registration Number: ISRCTN26269039
• Lead Sponsor: niversity of Edinburgh (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-05
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 152

Inclusion Criteria

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The first variceal bleed.<br><br>The outcomes were measured for the entire follow up period and also at 6, 12, and 24 months.

Secondary Outcome Measures

Name	Time	Method
1. Overall mortality<br>2. Variceal bleeding related mortality<br>3. Adverse events leading to treatment discontinuation<br><br>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.