Comparing imaging techniques in the management of liver disease
| ISRCTN | ISRCTN40384680 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40384680 |
| Secondary identifying numbers | 20729 |
- 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
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
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 |
|---|---|
| c.parsonage@imperial.ac.uk |
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 |
|---|---|
| s.taylor-robinson@imperial.ac.uk |
Study information
| Study design | Single-centre non-randomised diagnostic accuracy study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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. |
| 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 study start date | 03/03/2016 |
| Completion date | 31/05/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 100; UK Sample Size 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
- England
- United Kingdom
Study participating centre
London
W2 1PE
United Kingdom
Sponsor information
University/education
Joint Research Compliance Office
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
England
United Kingdom
"ROR" |
https://ror.org/041kmwe10 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal in 2019. |
| 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? |
|---|---|---|---|---|---|
| Protocol file | version 2.0 | 30/11/2015 | 11/10/2022 | No | No |
| 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 |
Additional files
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.
