Carvedilol tablets compared with endoscopic banding treatment in preventing rebleeding from oesophgaeal varices

ISRCTN ISRCTN69643049
DOI https://doi.org/10.1186/ISRCTN69643049
EudraCT/CTIS number 2006-000670-74
Secondary identifying numbers RN03GA006
Submission date
19/11/2013
Registration date
06/12/2013
Last edited
18/10/2016
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

Background and study aims
In patients with chronic liver disease, rebleeding after a first variceal bleed (bleeding from the blood vessels in the oesophagus [food pipe] or stomach) is common, but is reduced by endoscopic therapy (band ligation) of the varices (dilated blood vessels). Initial studies have suggested that propranolol with or without isosorbide mononitrate tablets may be equally effective in reducing rebleeding and are cheaper and easier to take.
Recent data suggests that carvedilol tablets may be the best medical therapy to reduce the risk of variceal bleeding. Therefore our aim was to investigate whether oral carvedilol therapy was superior to standard endoscopic band ligation at preventing rebleeding following a first variceal bleed.

Who can participate?
We aim to recruit 152 patients, male or female, aged between 18 and 75 with a diagnosis of oesophageal variceal bleeding and cirrhosis.

What does the study involve?
Patients who are stable in hospital after a first variceal bleed will be invited to enter the study. Eligible patients who consent will be randomly allocated to receive either oral carvedilol (6.25 mg for one week, then 12.5 mg daily thereafter) or standard endoscopic band ligation of their varices. Patients will be followed up until 6 months after the last patient is allocated.

What are the possible benefits and risks of participating?
There will be no immediate direct benefit to those taking part. However, there should be benefits to future patients because the results of the study are likely to influence how we treat similar patients in the future. The risks of carvedilol therapy are the same as those of any tablet which may reduce blood pressure, including dizziness or fainting.

Where is the study run from?
This multicentre study is being run from Glasgow Royal Infirmary. Patients will be recruited in Scotland, from Glasgow Royal Infirmary (the lead coordinating centre), the Royal Infirmary of Edinburgh, Gartnavel General Hospital Glasgow and the Southern General Hospital Glasgow.

When is the study starting and how long is it expected to run for?
The recruitment started in June 2006 and will run until the estimated number of patients has been recruited, which is expected to be end of 2013.

Who is funding the study?
Greater Glasgow & Clyde Health Board (UK).

Who is the main contact?
Dr Adrian Stanley
adrian.stanley@ggc.scot.nhs.uk

Contact information

Dr Adrian Stanley
Scientific

c/o GI Unit
Glasgow Royal Infrimary
Castle St
Glasgow
G4 OSF
United Kingdom

Phone +44 141 211 4073
Email adrian.stanley@ggc.scot.nhs.uk

Study information

Study designRandomised controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleMulticentre randomised controlled study comparing carvedilol with endoscopic band ligation in the prevention of variceal rebleeding
Study objectivesThe aim of this study is to investigate whether therapy with oral carvedilol tablets superior to endoscopic variceal band ligation in preventing rebleeding from varices.
Ethics approval(s)Glasgow Royal Infirmary North Glasgow NHS Trust Ethics Committee, 26/04/2004, ref: 03GA006
Health condition(s) or problem(s) studiedVariceal rebleeding in cirrhotic patients
InterventionOral carvedilol tablets versus endoscopic band ligation

Carvedilol is 6.25 mg once daily for one week and if tolerated then 12.5 mg once daily until the study is completed (6 months after the last patient is randomised)

Band ligation is done every 2-3 weeks until eradication then patient is endoscoped 6 monthly, with further bands applied as necessary.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Carvedilol
Primary outcome measureVariceal rebleeding is monitored when it occurs during follow-up. Patients will be followed up until 6 months after the last patient is randomised.
Secondary outcome measures1. Mortality
2. Any upper gastointestinal bleeding is monitored when it occurs during follow-up
Overall study start date06/06/2006
Completion date31/12/2013

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants152
Key inclusion criteria1. Male or female aged ≥18 and <75yrs
2. Endoscopic diagnosis of oesophageal variceal bleeding
3. Cirrhosis (based on previous liver biopsy or clinical, biochemical and ultrasonographic findings)
Key exclusion criteria1. Age <18 or >75 years
2. Advanced malignancy or another condition associated with a life expectancy of < 6/12 months
3. Previous transjugular intrahepatic portosystemic shunt (TIPS) or porto-caval shunt surgery
4. Portal vein thrombosis
5. Obstructive airways disease
6. Severe peripheral vascular disease
7. Heart block
8. Severe heart failure
9. Pregnancy
10. Type I diabetes mellitus
11. Gastric variceal bleed
12. Treatment with beta blockers or alpha blockers within 4 weeks of index bleed
Date of first enrolment06/06/2006
Date of final enrolment31/12/2013

Locations

Countries of recruitment

  • United Kingdom

Study participating centre

c/o GI Unit
Glasgow
G4 OSF
United Kingdom

Sponsor information

Greater Glasgow & Clyde (UK)
Hospital/treatment centre

R&D Department
38 Church St
Tennant Institute
Glasgow Biomedicine
1st Floor
Western Infirmary
Glasgow
G11 6NT
Scotland
United Kingdom

Phone +44 141 232 1813
Email maureen.travers@ggc.scot.nhs.uk
ROR logo "ROR" https://ror.org/05kdz4d87

Funders

Funder type

Hospital/treatment centre

Greater Glasgow & Clyde Health Board (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2014 Yes No

Editorial Notes

18/10/2016: Publication reference added.