Liver disease early detection study

ISRCTN	ISRCTN40804377
DOI	https://doi.org/10.1186/ISRCTN40804377
Secondary identifying numbers	16718

Submission date: 26/06/2014
Registration date: 06/08/2014
Last edited: 03/05/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Mrs Judy Chatwin
Scientific

Primary Medical Care
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom

Email	J.Chatwin@soton.ac.uk

Dr Magdy El-Gohary
Scientific

Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom

ORCID ID	0000-0001-8660-4355
Email	M.El-Gohary@soton.ac.uk

Study information

Study design	Non-randomised; Observational; Design type: Validation of investigational/therapeutic procedures
Primary study design	Observational
Secondary study design	Non randomised controlled trial
Study setting(s)	GP practice
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Fibroscan elastography staging of liver disease in participants from the ALDDeS study
Study objectives	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(s)	14/SC/0002; First MREC approval date 14/01/2014
Health condition(s) or problem(s) studied	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
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 study start date	11/03/2014
Completion date	18/07/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	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
Key inclusion criteria	Participants from the previous study ALDDES who were found to be at a possible or probable risk of liver fibrosis
Key exclusion criteria	Known pre-existing liver disease
Date of first enrolment	11/03/2014
Date of final enrolment	18/07/2015

Locations

Countries of recruitment

England
United Kingdom

Study participating centres

Aldermoor Health Centre

Southampton
SO16 5ST
United Kingdom

GP surgeries in Hampshire and Wiltshire

Sponsor information

University of Southampton (UK)
University/education

Southampton Primary Care Academic Unit
School of Medicine
Aldermoor Close
Southampton
SO16 5ST
England
United Kingdom

Email	J.Chatwin@soton.ac.uk
"ROR"	https://ror.org/01ryk1543

Funders

Funder type

Government

National Institute for Health Research School for Primary Care Research (UK); Grant Codes: 241
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date	31/12/2017
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

Editorial Notes

03/05/2017: The overall trial end date was changed from 03/11/2014 to 18/07/2015.