Plain English Summary
Background and study aims
Between 1970 and 2010, death rates from liver disease have increased five-fold in the UK, with the vast majority of deaths due to alcohol-related liver disease. It is difficult to detect the development of liver disease as patients tend not to have symptoms in the early stages. Although half of patients who eventually come into contact with liver specialist services will stop drinking, half of this group die before their livers are able to recover. One third of patients admitted to hospital with alcohol-related liver disease will die within a year from a complication of their illness. However, those who survive this period are likely to do well if they stop drinking. In the recent ALDDeS study, ,blood tests were taken for patients with a high alcohol intake to look for evidence of developing liver disease. It was found that about half of patients had a high or possible risk of liver disease, and these patients were shown to reduce their drinking up to a year after the tests. The study was based in GP surgeries and showed that it is possible to identify patients at risk of liver disease. In this study, a separate test to assess for liver disease (liver elastography) is tested. This is a simple, non-invasive test that involves measuring how stiff the liver is with a probe; there are no complications or side effects. The aim of this study is to see how accurate liver elastography is compared with the blood tests, and the possibility of using these tests in a GP practice.
Who can participate?
Patients identified in the ALDDeS study at high risk of liver disease will be invited to participate.
What does the study involve?
The study involves attending one mutually agreed, 30-minute appointment with a member of the study team at a GP practice. Participants complete a short alcohol questionnaire and answer some further questions about their alcohol consumption. They are then offered a repeat of the blood test that they had in the ALDDeS study, and have their liver assessed by elastography, which is similar to having an ultrasound scan of the liver. This procedure is painless and takes about 5-10 minutes. Participants receive a letter with their test results from the study team, which is copied to their GP.
What are the possible benefits and risks of participating?
The possible benefit is that participants suspected of having early liver disease can be alerted and referred for specialist consultation as necessary. The wider benefits include helping the study team see how useful each test is in helping identify those people who are silently developing liver disease. There are no risks as such in participating, although sometimes it is not always possible to obtain an accurate elastography reading in some people.
Where is the study run from?
The study sites are eight GP surgeries in and around the Southampton area (UK) that were previously involved in the ALDDeS study:
1. Three Swans Surgery, Salisbury Wiltshire
2. Nightingale Surgery, Romsey, Hampshire
3. Brockenhurst Surgery, New Forest Medical Group, Hampshire
4. Wilton Health Centre, Salisbury, Wiltshire
5. Rosemary Medical Centre, Poole, Dorset
6. Endless Street Surgery, Salisbury, Wiltshire
7. Gosport Medical Centre, Gosport, Hampshire
8. Oakley and Overton Surgery, Overton, Hampshire
When is the study starting and how long is it expected to run for?
March 2014 to November 2014
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Mrs Judy Chatwin
J.Chatwin@soton.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Judy Chatwin
ORCID ID
Contact details
Primary Medical Care
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
-
J.Chatwin@soton.ac.uk
Type
Scientific
Additional contact
Dr Magdy El-Gohary
ORCID ID
http://orcid.org/0000-0001-8660-4355
Contact details
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
-
M.El-Gohary@soton.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
16718
Study information
Scientific title
Fibroscan elastography staging of liver disease in participants from the ALDDeS study
Acronym
Study hypothesis
The principal question is to assess for the presence of liver fibrosis using liver elastography, in a community population already deemed high risk of liver disease using serum fibrosis markers (Southampton Traffic Light test), and to assess if there is any correlation between the two methods.
Ethics approval
14/SC/0002; First MREC approval date 14/01/2014
Study design
Non-randomised; Observational; Design type: Validation of investigational/therapeutic procedures
Primary study design
Observational
Secondary study design
Non randomised controlled trial
Trial setting
GP practices
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Topic: Primary Care; Subtopic: Not Assigned; Disease: All Diseases
Intervention
The study involves attending one mutually agreed, 30-minute appointment with a member of the study team at a GP practice. Participants complete a short alcohol questionnaire and answer some further questions about their alcohol consumption. They are then offered a repeat of the blood test that they had in the ALDDeS study (Southampton Traffic Light Test, a panel of serum fibrosis markers and platelet count blood test), and have their liver assessed by portable transient liver elastography (FibroScan). This procedure is painless and takes about 5-10 minutes. Participants receive a letter with their test results from the study team, which is copied to their GP.
Follow Up Length: 0 month(s); Study Entry: Registration only
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Positive predictive value of Southampton Traffic Light Test; Timepoint(s): On assessment with liver elastography
Secondary outcome measures
Not provided at time of registration
Overall trial start date
11/03/2014
Overall trial end date
18/07/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Participants from the previous study ALDDES who were found to be at a possible or probable risk of liver fibrosis
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 90; UK Sample Size: 90; Description: Participants from a previous study ALDDES who were assessed as a possible or probable risk of liver fibrosis
Participant exclusion criteria
Known pre-existing liver disease
Recruitment start date
11/03/2014
Recruitment end date
18/07/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Aldermoor Health Centre
Southampton
SO16 5ST
United Kingdom
Trial participating centre
GP surgeries in Hampshire and Wiltshire
-
Sponsor information
Organisation
University of Southampton (UK)
Sponsor details
Southampton Primary Care Academic Unit
School of Medicine
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
-
J.Chatwin@soton.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research School for Primary Care Research (UK); Grant Codes: 241
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Estimated date of publication is end 2017/early 2018.
IPD sharing plan
Planned dissemination of data in forthcoming publications related to ongoing work
Intention to publish date
31/12/2017
Participant level data
Other
Basic results (scientific)
Publication list