Stent Oesophageal Varices: Effective haemostasis using self-expandable covered mesh-metal oesophageal stents versus standard endoscopic therapy in the emergency treatment of oesophageal variceal haemorrhage
| ISRCTN | ISRCTN98310189 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98310189 |
| ClinicalTrials.gov number | NCT01851564 |
| Secondary identifying numbers | 13392 |
- Submission date
- 03/05/2013
- Registration date
- 03/05/2013
- Last edited
- 25/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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
Contact information
Scientific
Royal Free Hospital
Pond Street
London
NW3 2QG
United Kingdom
| Phone | +44 20 7794 0500 |
|---|---|
| brianhogan@nhs.net |
Study information
| Study design | Multicentre open prospective randomised controlled treatment study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 acronym | SOV |
| Study objectives | 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(s) | 11/LO/1873 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 22/08/2012 |
| Completion date | 31/08/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | UK Sample Size: 136 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 22/08/2012 |
| Date of final enrolment | 31/08/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
NW3 2QG
United Kingdom
Sponsor information
University/education
Gower Street
London
WC1E 6BT
England
United Kingdom
| Phone | +44 20 7679 2000 |
|---|---|
| rfh.randd@nhs.net | |
| Website | http://www.ucl.ac.uk/ |
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
25/04/2019: No publications found. Verifying results with principal investigator.
17/01/2017: No publications found in PubMed, verifying study status with principal investigator.
