Randomised controlled trial for the prevention of first variceal bleeding in cirrhotic patients with contraindications or intolerance to B-blockers (ligation versus no treatment)

ISRCTN	ISRCTN95937358
DOI	https://doi.org/10.1186/ISRCTN95937358
Secondary identifying numbers	N0256111238

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 07/09/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Andrew K Burroughs
Scientific

Department of Liver Medicine/Transplantation
Royal Free Hampstead NHS Trust
Pond Street
Hampstead
London
NW3 2QG
United Kingdom

Phone	+44 (0)20 7472 0229 ext. 3978
Email	andrew.burroughs@talk21.com

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Scientific title
Study objectives	Prophylactic banding in patients with contraindications to receive beta-blockers.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Variceal bleeding
Intervention	A randomised controlled trial was designed, which will include cirrhotic patients with endoscopically documented varices and contraindications or intolerance to beta-blockers. Patients will be recruited during the outpatient clinic or on the wards. The enrolled patients will be randomised to receive prophylactic banding or no treatment. Patients randomised to banding will be banded weekly until total variceal obliteration is achieved at this point will have 3 monthly surveillance, as the usual practice. Patients will be asked to record all complaints. Patients randomised to no treatment will have their routine follow-up and yearly endoscopy. All patients should continued to be followed-up until at least 24 months.
Intervention type	Other
Primary outcome measure	To compare in a randomised controlled trial whether endoscopic variceal ligation (EVL) therapy reduces the risk of first variceal bleeding compared to no-therapy and improves chances of survival in cirrhotic patients with contraindication or intolerance to B-blockers.
Secondary outcome measures	Not provided at time of registration
Overall study start date	12/12/1999
Completion date	15/06/2003

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	214 patients (107 will receive prophylactic banding, 107 in control group)
Key inclusion criteria	214 cirrhotic patients with contraindications to receive beta-blockers
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	12/12/1999
Date of final enrolment	15/06/2003

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Liver Medicine/Transplantation

London
NW3 2QG
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

The Royal Free Hampstead NHS Trust. (UK) Own account

No information available

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	15/06/2005		Yes	No