Real-time Elastography for Non-invasive Assessment of Liver Fibrosis and Fat Quantification Techniques for Assessment of Fatty Change in Chronic Liver Disease

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Liver stiffness is a marker for scarring of the liver, which occurs after damage from various liver conditions. Scarring prevents normal liver function and can lead to liver failure. Fatty liver is a common cause of liver damage and can contribute to scarring. Currently, liver biopsy serves as the 'gold standard' for assessing the degree of liver scarring and fatty infiltration, guiding treatment decisions. However, liver biopsy poses a significant risk of death and unpleasant side effects, including internal bleeding and pain. Moreover, due to the small sample of liver tissue obtained during the biopsy, the results can be misleading and may not provide an accurate overview of the liver's health. Therefore, there is an unmet need for a non-invasive method of measuring liver stiffness and fat content. Ultrasound-based methods utilize various properties of ultrasound waves to assess liver stiffness and fat levels. This study aims to recruit 100-120 patients with chronic liver disease. The investigators will assess liver stiffness and fat levels during patients' hospital visits for routine scans, biopsies, or clinic appointments. The resulting measurements of liver stiffness and fat obtained through ultrasound-based methods will be compared to patients' routine liver biopsies, routine FibroScan results (another non-invasive method routinely used in clinical care to assess patients' liver stiffness), and other non-invasive severity scores (calculated from results obtained from patients' routine blood tests, providing an overview of the extent of liver damage).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• \>=18 years old

• Male or Female

• Suspected chronic liver disease based on clinical history, serum biochemistry, prior imaging or prior liver biopsy

• Willing and able to provide written informed consent.

Locations
Other Locations
United Kingdom
Nuran Seneviratne
RECRUITING
London
Contact Information
Primary
Cheng Fang
chengfang@nhs.net
07809747718
Backup
Paul Sidhu
paulsidhu@nhs.net
Time Frame
Start Date: 2023-01-02
Estimated Completion Date: 2025-07-02
Participants
Target number of participants: 180
Treatments
Experimental: Liver Biopsy Cohort
Sponsors
Leads: King's College Hospital NHS Trust
Collaborators: Samsung Medison

This content was sourced from clinicaltrials.gov