Effectiveness of ultrasound in liver stiffness and fat quantification

  • Research type

    Research Study

  • Full title

    Liver point and 2-D elastography for non-invasive assessment of fibrosis and fat quantification techniques for assessment of fatty change in chronic liver disease

  • IRAS ID

    212836

  • Contact name

    Paul Sidhu

  • Contact email

    paulsidhu@nhs.net

  • Sponsor organisation

    King's College Hospital NHS Foundation Trust

  • Clinicaltrials.gov Identifier

    NCT06111859

  • Clinicaltrials.gov Identifier

    N/A, N/A

  • Duration of Study in the UK

    2 years, 0 months, 1 days

  • Research summary

    Liver stiffness is a marker for scarring of the liver which happens after damage from various liver conditions, scarring prevents normal liver function and causes liver failure. Fatty liver is a common cause of liver damage and can lead to scarring.

    Liver biopsy is currently the ‘gold standard’ in assessing the degree of liver scarring and fatty infiltration, which guides treatment and measures its response. However, there is a significant risk of death and unpleasant side-effects related to liver biopsy, including internal bleeding and pain. Due to the small sample of liver tissue taken during the biopsy, the result can be misleading and may not give an accurate overview of the health of the liver. So, there is a current unmet need for a non-invasive method of measuring liver stiffness and fat content.

    Ultrasound-based methods use various properties of the ultrasound waves to assess the stiffness of the liver and the fat levels. This study will recruit 100-120 patients with chronic liver disease. We will assess the liver stiffness and fat levels when patients attend the hospital for a routine scan, biopsy, or clinic appointment. The resulting measure of liver stiffness and fat that we get from the ultrasound-based methods will be compared to the patient’s routine liver biopsy; routine FibroScan results (another non-invasive method used routinely in clinical care to assess patients’ liver stiffness) and other non-invasive severity scores (calculated from results obtained from patient’s routine blood tests which can give an overview of how damaged the patients’ liver is).

  • REC name

    North West - Greater Manchester South Research Ethics Committee

  • REC reference

    22/NW/0401

  • Date of REC Opinion

    21 Dec 2022

  • REC opinion

    Favourable Opinion