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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Peter Hayes
Scientific

Department of Hepatology
University of Edinburgh
Little France
Edinburgh
EH16 4SA
United Kingdom

Phone	+44 (0)131 242 1625
Email	p.hayes@ed.ac.uk

Primary study design	Interventional
Study design	Prospective multicentre randomised controlled clinical trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Carvedilol, a vasodilating non-selective beta blocker is more effective than variceal band ligation in the prevention of the first variceal bleed in patients with high risk varices.
Ethics approval(s)	Ethical approval obtained from Lothian Research Ethics Committee on 14th February 2000.
Health condition(s) or problem(s) studied	Cirrhosis and portal hypertension
Intervention	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 follow up periods for the carvedilol and banding arms are 23.3 ± 21.1 months and 22.1 ± 22.3 months respectively.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Carvedilol
Primary outcome measure(s)	The first variceal bleed. The outcomes were measured for the entire follow up period and also at 6, 12, and 24 months.
Key secondary outcome measure(s)	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.
Completion date	24/05/2006

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	152
Key inclusion criteria	Liver cirrhosis and the presence of Grade II or larger oesophageal varices.
Key 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
Date of first enrolment	14/02/2000
Date of final enrolment	24/05/2006

Department of Hepatology

Edinburgh
EH16 4SA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2009		Yes	No