Condition category
Circulatory System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
07/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes