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
Protocol serial number	N0256111238
Sponsor	Department of Health (UK)
Funder	The Royal Free Hampstead NHS Trust. (UK) Own account

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	15/06/2003

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	214
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

Department of Liver Medicine/Transplantation

London
NW3 2QG
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	15/06/2005		Yes	No