Comparing imaging techniques in the management of liver disease

Not Applicable

Completed

• Conditions: Topic: Hepatology; Subtopic: Hepatology; Disease: All Hepatology; Digestive System; Liver disease

• Registration Number: ISRCTN40384680
• Lead Sponsor: Imperial College London

Brief Summary

2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/37325088/ Use of Fibroscan to diagnose hepatic steatosis (added 05/09/2023) 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/33312429/ Use of Philips Affinit 70 (ElastPQ) to assess liver and spleen stiffness in patients with and without clinically significant portal hypertension (added 05/09/2023) 2019 Other publications in https://pubmed.ncbi.nlm.nih.gov/31764798/ Use of Philips EPIQ7 to assess liver and spleen stiffness in three groups of patients with HIV infection (added 05/09/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-17
• Study Completion: 2018-05-31
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 155

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

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