Comparing imaging techniques in the management of liver disease

ISRCTN	ISRCTN40384680
DOI	https://doi.org/10.1186/ISRCTN40384680
Protocol serial number	20729
Sponsor	Imperial College London
Funder	Philips Ultrasound Inc.

Submission date: 17/03/2016
Registration date: 17/03/2016
Last edited: 05/09/2023

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
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 7™ Ultrasound System, the Siemens Acuson (ARFI) Ultrasound System, and by Echosens Fibroscan™ (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

Contact information

Ms Claire Parsonage
Public

Imperial College London
Department of Hepatology
10th Floor QEQM Building
St Mary's Hospital
Praed Street
London
W2 1PE
United Kingdom

Phone	+44 1285 650696
Email	c.parsonage@imperial.ac.uk

Prof Simon Taylor-Robinson
Scientific

Imperial College London
Department of Hepatology
10th Floor QEQM Building
St Mary's Hospital
Praed Street
London
W2 1NY
United Kingdom

Phone	+44 20 3312 6454
Email	s.taylor-robinson@imperial.ac.uk

Study information

Primary study design	Interventional
Study design	Single-centre non-randomised diagnostic accuracy study
Secondary study design	Non randomised study
Study type	Participant information sheet
Scientific title	The role of ultrasound shear wave elastography in the management of liver disease
Study objectives	The aim of this study is to correlate liver stiffness assessed by the Philips EPIQ 7™ Ultrasound System, the Siemens Acuson (ARFI) ultrasound system, and by Fibroscan™ (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(s)	East of England - Cambridge East Research Ethics Committee, 03/12/2015, ref: 15/EE/0420
Health condition(s) or problem(s) studied	Topic: Hepatology; Subtopic: Hepatology; Disease: All Hepatology
Intervention	Imaging using the Philips EPIQ 7™ Ultrasound System, the Siemens Acuson (ARFI) Ultrasound System, and by Echosens Fibroscan™ (which is currently the best validated technique).
Intervention type	Other
Primary outcome measure(s)	To correlate liver stiffness assessed by the Philips EPIQ 7™ Ultrasound System, the Siemens Acuson (ARFI) ultrasound system, and by Echosens Fibroscan™ (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.
Key secondary outcome measure(s)	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)
Completion date	31/05/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	100
Total final enrolment	155
Key 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
Key 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
Date of first enrolment	03/03/2016
Date of final enrolment	22/12/2016

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

St. Mary's Hospital

Praed Street
London
W2 1PE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	The datasets generated during and/or analysed during the current study are not expected to be made available.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No
Other publications	Use of Fibroscan to diagnose hepatic steatosis	09/06/2023	05/09/2023	Yes	No
Other publications	Use of Philips Affinit 70 (ElastPQ) to assess liver and spleen stiffness in patients with and without clinically significant portal hypertension	27/11/2020	05/09/2023	Yes	No
Other publications	Use of Philips EPIQ7 to assess liver and spleen stiffness in three groups of patients with HIV infection	01/11/2019	05/09/2023	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	version 2.0	30/11/2015	11/10/2022	No	No

Additional files

31873 Protocol V2.0 30Nov2015.pdf: Protocol file

Editorial Notes

05/09/2023: Publication references added.
11/10/2022: Uploaded protocol (not peer-reviewed) as an additional file.
22/12/2020: Internal review.
27/03/2019: The following changes were made to the trial record:
1. The overall trial end date was changed from 03/03/2018 to 31/05/2018.
2. The final total enrolment number was added (155 participants).
3. Publication and dissemination plan and IPD sharing statement added.
23/10/2017: Internal review.