Contact information
Type
Scientific
Primary contact
Dr Andrew K Burroughs
ORCID ID
Contact details
Department of Liver Medicine/Transplantation
Royal Free Hampstead NHS Trust
Pond Street
Hampstead
London
NW3 2QG
United Kingdom
+44 (0)20 7472 0229 ext. 3978
andrew.burroughs@talk21.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0256111238
Study information
Scientific title
Acronym
Study hypothesis
Prophylactic banding in patients with contraindications to receive beta-blockers.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
12/12/1999
Overall trial end date
15/06/2003
Reason abandoned
Eligibility
Participant inclusion criteria
214 cirrhotic patients with contraindications to receive beta-blockers
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
214 patients (107 will receive prophylactic banding, 107 in control group)
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
12/12/1999
Recruitment end date
15/06/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Liver Medicine/Transplantation
London
NW3 2QG
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
The Royal Free Hampstead NHS Trust. (UK) Own account
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15948810
Publication citations
-
Results
Triantos C, Vlachogiannakos J, Armonis A, Saveriadis A, Kougioumtzian A, Leandro G, Manolakopoulos S, Tzourmakliotis D, Raptis SA, Burroughs AK, Avgerinos A, Primary prophylaxis of variceal bleeding in cirrhotics unable to take beta-blockers: a randomized trial of ligation., Aliment. Pharmacol. Ther., 2005, 21, 12, 1435-1443, doi: 10.1111/j.1365-2036.2005.02457.x.