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

Plain English Summary

Background and study aims
Twice as many people now die from liver disease than in 1991, making liver disease the fifth ‘big killer’ in England & Wales, with most deaths occurring in those under 60. Bleeding from veins in the gullet (Oesophageal varices) is one of the most serious complications of liver disease carrying a 1-in-5 risk of a patient dying. Current best treatments involve using medications to reduce bleeding and passing a camera, on the end of a narrow flexible tube called an endoscope, into the gullet to find the source of bleeding and stop it. Unfortunately the chances of this treatment failing to control the bleeding are about 1-in-4.
We are testing a device called a ‘stent’. This is a covered mesh-metal tube which is placed in the gullet using the endoscope. The stent expands to push on the walls of the gullet and stop the veins from bleeding.

Who can participate?
All patients who are admitted to participating hospitals with bleeding from veins in the gullet will be offered the opportunity to participate.

What does the study involve?
Participants will be randomly allocated to one of the two groups:
1. Oesophageal Stent
2. The best current treatments
This study will compare the new stent with the best current treatments

What are the possible benefits and risks of participating?
The stent as been used in a small number of patients and is currently reported to be 100% successful at stopping bleeding. There are some minor complications, which can occur with the stent such as inflammation of the gullet, acid reflux from the stomach and very rarely perforation of the gullet. These will be discussed in full with all potential participants.

Where is the study run from?
The Co-ordinating centre is the Royal Free Hospital.
There are 10 centres in total:
The Royal Free Hospital, London (Lead centre)
Bristol Royal Infirmary
The Royal London Hospital
Frimley Park Hospital, Surrey
Basildon & Thurrock University Hospitals
Royal Devon & Exeter Hospitals
Central Manchester University Hospitals
Royal Bournemouth Hospital, Dorset
Queen Alexandra Hospital, Portsmouth
University Hospitals Coventry & Warwickshire

When is the study starting and how long is it expected to run for?
The study is open now and will run until 2015.

Who is funding the study?
The study is being supported by a grant from ELLA CS (the company that make the stents), and by the National Institute of Health Research.

Who is the main contact?
Dr Brian Hogan

Trial website

Contact information



Primary contact

Dr Brian Hogan


Contact details

Royal Free Hospital
Pond Street
United Kingdom

Additional identifiers

EudraCT number number


Protocol/serial number


Study information

Scientific title

Effective haemostasis using self-expandable covered mesh-metal oesophageal stents versus standard endoscopic therapy in the emergency treatment of oesophageal variceal haemorrhage: A multicentre, open, prospective, randomised, controlled study



Study hypothesis

The self-expanding oesophageal stent will:
1. Provide superior haemostasis and a reduction in failure to control bleeding when compared to standard endoscopic therapy.
2. Be successfully implanted and well tolerated in >95% of the selected participants.
3. Be associated with fewer minor side-effects for the participant (thoracic pain, dysphagia), and with earlier introduction of oral feeding when compared to standard endoscopic therapy.

More details can be found at:

Ethics approval


Study design

Multicentre open prospective randomised controlled treatment 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


Topic: Blood, Oral and Gastrointestinal; Subtopic: Blood (all Subtopics), Oral and Gastrointestinal (all Subtopics); Disease: Non-malignant haematology, Hepatology


Oesophageal Stent compared with the best current treatments

Oesophageal Stent, A self-expanding mesh metal removable oesophageal stent.

Intervention type



Not Applicable

Drug names

Primary outcome measures

Failure to control bleeding (as defined by the Baveno V criteria) or re-bleeding within 7 days.

Secondary outcome measures

Not provided at time of registration

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

Arm 1:
Participants with Child-Pugh grade B or C cirrhosis with variceal haemorrhage, where the bleeding is from a site which would ordinarily be treated with band ligation (usually either oesophageal or GOV-1 varices). The diagnosis of cirrhosis may be proven by previous histology or suspected using clinical, radiological and biochemical data.

Arm 2: Participants with Child-Pugh grade A, B or C cirrhosis who present with failure to control bleeding within 5 days of an initial attempt at standard endoscopic therapy of acute haemorrhage from a site which would ordinarily be treated with band ligation (usually either oesophageal or GOV-1 varices).

Failure to control bleeding is demonstrated by the Baveno V criteria, either:

1. Fresh Haematemesis (or >100mls of fresh blood aspirated via NG >2 hours after therapeutic endoscopy)

2. Development of Hypovolaemic Shock

3. 3g drop in Haemoglobin within any 24 hours period if no transfusion is administered

Target Gender: Male & Female ; Lower Age Limit 18 years

Participant type


Age group




Target number of participants

UK Sample Size: 136

Participant exclusion criteria

1. < 18 Years of age
2. Child-Pugh grade A cirrhosis (Arm 1 only)
3. Non-cirrhotic portal hypertension
4. Malignancy of the oesophagus, stomach or upper respiratory tract
5. Oesophageal stenosis which prohibits endoscopy
6. Recent oesophageal surgery
7. A large hiatus hernia which prevents stent placement
8. Known hepatocellular carcinoma considered to be incurable (according to Milan Criteria).
9. Patients in the terminal phases of hepatological or other disease.
10. Pregnancy

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Royal Free Hospital
United Kingdom

Sponsor information


University College London (UK)

Sponsor details

Gower Street
United Kingdom

Sponsor type




Funder type


Funder name

ELLA - CS, s.r.o.

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes