Condition category
Digestive System
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

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

Trial website

Contact information



Primary contact

Dr Adrian Stanley


Contact details

c/o GI Unit
Glasgow Royal Infrimary
Castle St
United Kingdom
+44 141 211 4073

Additional identifiers

EudraCT number

2006-000670-74 number

Protocol/serial number


Study information

Scientific title

Multicentre randomised controlled study comparing carvedilol with endoscopic band ligation in the prevention of variceal rebleeding


Study hypothesis

The 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

Glasgow Royal Infirmary North Glasgow NHS Trust Ethics Committee, 26/04/2004, ref: 03GA006

Study design

Randomised controlled study

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Variceal rebleeding in cirrhotic patients


Oral 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 type



Not Applicable

Drug names


Primary outcome measure

Variceal 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 measures

1. Mortality
2. Any upper gastointestinal bleeding is monitored when it occurs during follow-up

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. 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)

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. 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

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

c/o GI Unit
United Kingdom

Sponsor information


Greater Glasgow & Clyde (UK)

Sponsor details

R&D Department
38 Church St
Tennant Institute
Glasgow Biomedicine
1st Floor
Western Infirmary
G11 6NT
United Kingdom
+44 141 232 1813

Sponsor type

Hospital/treatment centre



Funder type

Hospital/treatment centre

Funder name

Greater Glasgow & Clyde Health Board (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

2014 results in

Publication citations

Additional files

Editorial Notes

18/10/2016: Publication reference added.