Comparing two non-invasive strategies to diagnose advanced liver fibrosis in NAFLD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter interventional protocol compares two diagnostic algorithms (FIB4-FS and eLIFT-FMVCTE) for identifying advanced liver fibrosis in adults with NAFLD. Participants undergo routine blood tests and, where available, liver stiffness measurement (FibroScan) and results are compared against the reference diagnostic pathway used in specialist centers. The trial aims to validate prior findings from the population where eLIFT-FMVCTE was developed to avoid optimism bias. The goal is to identify which algorithm provides the best balance of accuracy and minimal need for liver biopsy in everyday clinical practice.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Presence of NAFLD as defined by :

   * The presence of liver steatosis as assessed by ultrasonography (bright liver) or magnetic resonance imaging/spectroscopy (fat fraction \>5.6%) or Controlled Attenuation Parameter (≥248 dB/m)
   * The absence of steatosis-inducing drugs (systemic corticosteroids, methotrexate, amiodarone, tamoxifen)
   * The absence of excessive alcohol consumption (\<210 g/week in men or \<140 g/week in women)
   * The absence of other causes of chronic liver disease (chronic viral hepatitis B or C, hemochromatosis, auto-immune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson disease alpha-1-antitrypsin deficiency).
2. Age ≥18 years and ≤80 years
3. Affiliated person or beneficiary of a social security regime
4. Written informed consent of the patient who agree to comply with the study protocol.

Exclusion Criteria:

1. Decompensated cirrhosis (ascites, variceal bleeding, hepatic encephalopathy, liver failure, hepato-renal syndrome)
2. Hepatocellular carcinoma
3. Inability to safely undergo liver biopsy
4. Participation in other intervention study with drug protocol treatment in progress at the time of inclusion or within one month prior to inclusion in the study.
5. Pregnant, breastfeeding or parturient woman
6. Person restricted by judicial or administrative decision
7. Person under psychiatric care under restraint
8. Person subject to a legal protection measure
9. Person unable to express consent

Where it's running

• University Hospital of Angers
  Angers, France Recruiting
• University Hospital of Dijon
  Dijon, France Recruiting
• Departemental Hospital Center of Vendée
  La Roche-sur-Yon, France Recruiting
• La Croix Rousse Hospital
  Lyon, France Recruiting
• University Hospital of Montpellier
  Montpellier, France Recruiting
• University Hospital of Besançon
  Besançon, France Not yet recruiting

Study contacts

• Study coordinator: Jérôme Boursier, MD-PHD
• Email: jeboursier@chu-angers.fr
• Phone: +33241353410

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.