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Randomised controlled trial of carvedilol versus variceal band ligation in the primary prophylaxis of oesophageal variceal haemorrhage
ISRCTN ISRCTN26269039
DOI 10.1186/ISRCTN26269039
ClinicalTrials.gov identifier
EudraCT number
Public title Randomised controlled trial of carvedilol versus variceal band ligation in the primary prophylaxis of oesophageal variceal haemorrhage
Scientific title
Acronym N/A
Serial number at source LREC/1999/4/197
Study hypothesis 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.
Lay summary
Ethics approval Ethical approval obtained from Lothian Research Ethics Committee on 14th February 2000.
Study design Prospective multicentre randomised controlled clinical trial
Countries of recruitment United Kingdom
Disease/condition/study domain Cirrhosis and portal hypertension
Participants - inclusion criteria Liver cirrhosis and the presence of Grade II or larger oesophageal varices.
Participants - 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
Anticipated start date 14/02/2000
Anticipated end date 24/05/2006
Status of trial Completed
Patient information material
Target number of participants 152
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 follow up periods for the carvedilol and banding arms are 23.3 ± 21.1 months and 22.1 ± 22.3 months respectively.
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.
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.
Sources of funding University of Edinburgh (UK)
Trial website
Publications 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19610055
Contact name Prof  Peter  Hayes
  Address Department of Hepatology
University of Edinburgh
Little France
  City/town Edinburgh
  Zip/Postcode EH16 4SA
  Country United Kingdom
  Tel +44 (0)131 242 1625
  Email p.hayes@ed.ac.uk
Sponsor University of Edinburgh (UK)
  Address Royal Infirmary
Little France
  City/town Edinburgh
  Zip/Postcode EH16 4SB
  Country United Kingdom
  Email mvm@ed.ac.uk
  Sponsor website: http://www.ed.ac.uk/
Date applied 09/06/2007
Last edited 21/09/2009
Date ISRCTN assigned 05/07/2007
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