Condition category
Digestive System
Date applied
17/03/2016
Date assigned
17/03/2016
Last edited
19/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Liver disease refers to a group of conditions which prevent the liver from working as well as it should do. The liver is the second largest organ in the body, performing a number of vital functions. It is responsible for removing toxins (poisons) from the body, releasing bile (a liquid that helps to break down fat during digestion) and helps blood to clot. There are over 100 different types of liver disease, and there are often no obvious symptoms until the liver is already badly damaged. In most types of liver disease, the liver becomes extensively scarred (fibrosis), which if left untreated can lead to complete liver failure. Although a biopsy (taking a tissue sample) is often needed to diagnose liver disease, ultrasound scanning is also widely used in diagnosis and monitoring. This is a safe and painless procedure that uses the way sound waves bounce off different types of tissue inside the body to produce a picture on a screen. Transient elastography (TE) is a scanning technique used to measure the stiffness of the liver. A probe placed on the skin produces a wave of vibration called a ‘shear wave’. The time that it takes for this wave to travel to a particular depth in the liver is measured and used to calculate the liver stiffness. If the liver is scarred (fibrosis), then it takes longer for the shear wave to travel through the tissue. Fibroscan (an ultrasound machine made by Echosens) is currently the best technique for detecting liver disease (gold standard), however there are other ultrasound systems available. This study will determine the reliability of Philips Affiniti Elast PQ Ultrasound System for the assessment of liver fibrosis, by comparing it to two other systems (Siemens ARFI Acuson S2000 Ultrasound System and the Fibroscan system made by Echosens).

Who can participate?
Adults with long-term (chronic) liver disease who is about to have, or has recently had, a sample of tissue taken from their liver (biopsy).

What does the study involve?
All participants undergo three ultrasound scans of their liver using the Philips EPIQ 7TM Ultrasound System, the Siemens Acuson (ARFI) Ultrasound System, and by Echosens FibroscanTM (which is currently the best technique – gold standard). The results of the three scans are then compared to liver biopsy results of the patients in order to find out which is the most accurate technique.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
St. Mary's Hospital, London (UK)

When is the study starting and how long is it expected to run for?
March 2016 to March 2018

Who is funding the study?
Philips Ultrasound Inc. (UK)

Who is the main contact?
1. Ms Claire Parsonage (public)
c.parsonage@imperial.ac.uk
2. Professor Simon Taylor-Robinson (scientific)
s.taylor-robinson@imperial.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Ms Claire Parsonage

ORCID ID

Contact details

Imperial College London
Department of Hepatology
10th Floor QEQM Building
St Mary's Hospital
Praed Street
London
W2 1PE
United Kingdom
+44 1285 650696
c.parsonage@imperial.ac.uk

Type

Scientific

Additional contact

Prof Simon Taylor-Robinson

ORCID ID

Contact details

Imperial College London
Department of Hepatology
10th Floor QEQM Building
St Mary's Hospital
Praed Street
London
W2 1NY
United Kingdom
+44 20 3312 6454
s.taylor-robinson@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

20729

Study information

Scientific title

The role of ultrasound shear wave elastography in the management of liver disease

Acronym

Study hypothesis

The aim of this study is to correlate liver stiffness assessed by the Philips EPIQ 7TM Ultrasound System, the Siemens Acuson (ARFI) ultrasound system, and by FibroscanTM (which is currently the best validated technique), and compare the results of these 3 imaging techniques to histological results in patients with chronic liver disease of different aetiologies.

Ethics approval

East of England - Cambridge East Research Ethics Committee, 03/12/2015, ref: 15/EE/0420

Study design

Single-centre non-randomised diangostic accuracy study.

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Hepatology; Subtopic: Hepatology; Disease: All Hepatology

Intervention

Imaging using the Philips EPIQ 7TM Ultrasound System, the Siemens Acuson (ARFI) Ultrasound System, and by Echosens FibroscanTM (which is currently the best validated technique).

Intervention type

Other

Phase

Drug names

Primary outcome measures

To correlate liver stiffness assessed by the Philips EPIQ 7TM Ultrasound System, the Siemens Acuson (ARFI) ultrasound system, and by Echosens FibroscanTM (which is currently the best validated technique), and compare the results of these 3 imaging techniques to histological results in patients with chronic liver disease of different aetiologies.

Secondary outcome measures

1. Cut-off values of the liver stiffness (LS) measurements that correlate to the histological fibrosis stage
2. Variations of the liver stiffness (LS) measurements correlated to different parameters
3. Quality parameters (IQR and SR) for the liver stiffness (LS) measurements
4. Ability of distinguishing non-alcoholic steatohepatitis (NASH) from non-alcoholic fatty liver disease (NAFLD)

Overall trial start date

03/03/2016

Overall trial end date

03/03/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Able and willing to provide written informed consent
2. Aged between 18 and 75
3. Chronic liver disease
4. About to undergo a liver biopsy as part of standard routine clinical care, or if a liver biopsy has recently been performed, and is willing to come in for a specific research visit for the 3 scans
5. Willing to consent to medical notes and diagnostic test results being reviewed, captured, and recorded by the clinical research study team

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 100; UK Sample Size 100

Participant exclusion criteria

1. Unable or unwilling to give written informed consent
2. Aged under 18 or over 75
3. No evidence of liver disease
4. Pregnancy
5. Patients with pacemakers fitted

Recruitment start date

03/03/2016

Recruitment end date

22/12/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St. Mary's Hospital
Praed Street
London
W2 1PE
United Kingdom

Sponsor information

Organisation

Imperial College London

Sponsor details

Joint Research Compliance Office
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Philips Ultrasound Inc.

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

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes