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 (UK)
There are 10 UK 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
brianhogan@nhs.net
Trial website
Contact information
Type
Scientific
Primary contact
Dr Brian Hogan
ORCID ID
Contact details
Royal Free Hospital
Pond Street
London
NW3 2QG
United Kingdom
+44 20 7794 0500
brianhogan@nhs.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT01851564
Protocol/serial number
13392
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
Acronym
SOV
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
Ethics approval
11/LO/1873
Study design
Multicentre open prospective randomised controlled treatment study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Blood, Oral and Gastrointestinal; Subtopic: Blood (all Subtopics), Oral and Gastrointestinal (all Subtopics); Disease: Non-malignant haematology, Hepatology
Intervention
Oesophageal Stent compared with the best current treatments
Oesophageal Stent, A self-expanding mesh metal removable oesophageal stent.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
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
22/08/2012
Overall trial end date
31/08/2014
Reason abandoned (if study stopped)
Eligibility
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
Patient
Age group
Adult
Gender
Both
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
22/08/2012
Recruitment end date
31/08/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Free Hospital
London
NW3 2QG
United Kingdom
Sponsor information
Organisation
University College London (UK)
Sponsor details
Gower Street
London
WC1E 6BT
United Kingdom
+44 20 7679 2000
rfh.randd@nhs.net
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
ELLA - CS, s.r.o.
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
Basic results (scientific)
Publication list