Randomised controlled trial of carvedilol versus variceal band ligation in the primary prophylaxis of oesophageal variceal haemorrhage
| ISRCTN | ISRCTN26269039 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26269039 |
| Secondary identifying numbers | LREC/1999/4/197 |
- Submission date
- 09/06/2007
- Registration date
- 05/07/2007
- Last edited
- 21/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Peter Hayes
Scientific
Scientific
Department of Hepatology
University of Edinburgh
Little France
Edinburgh
EH16 4SA
United Kingdom
| Phone | +44 (0)131 242 1625 |
|---|---|
| p.hayes@ed.ac.uk |
Study information
| Study design | Prospective multicentre randomised controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Carvedilol |
| Primary outcome measure | The first variceal bleed. The outcomes were measured for the entire follow up period and also at 6, 12, and 24 months. |
| Secondary outcome measures | 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. |
| Overall study start date | 14/02/2000 |
| Completion date | 24/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Department of Hepatology
Edinburgh
EH16 4SA
United Kingdom
EH16 4SA
United Kingdom
Sponsor information
University of Edinburgh (UK)
University/education
University/education
Royal Infirmary
Little France
Edinburgh
EH16 4SB
Scotland
United Kingdom
| mvm@ed.ac.uk | |
| Website | http://www.ed.ac.uk/ |
"ROR" |
https://ror.org/01nrxwf90 |
Funders
Funder type
University/education
University of Edinburgh (UK)
Government organisation / Universities (academic only)
Government organisation / Universities (academic only)
- Alternative name(s)
- Universitas Academica Edinburgensis, Oilthigh Dhùn Èideann, The University of Edinburgh, University of Edinburgh in United Kingdom, Edin, Tounis College, King James' College, Athens of the North, ED, Edin
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2009 | Yes | No |
