Condition category
Digestive System
Date applied
26/06/2014
Date assigned
06/08/2014
Last edited
03/05/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Federal/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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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