Screening for liver fibrosis in at-risk populations using non-invasive methods

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 study aims to screen at-risk populations for advanced liver fibrosis using transient elastography and other non-invasive serum and imaging markers. Conducted at Odense University Hospital, it will involve 3000 participants from at-risk groups, such as those with a history of alcohol overuse or metabolic syndrome, and 3500 participants from the general population. The study will evaluate the effectiveness of these screening tools in detecting advanced fibrosis and compare novel serum markers against transient elastography. Participants with elevated liver stiffness will undergo further investigations, including elastography and liver biopsy, to confirm fibrosis status.

Why it matters

Who can join: the full rules

INCLUSION CRITERIA

Patients are eligible for screening if the following inclusion criteria are fulfilled:

* Age 30-75 years (except the general population, which should be aged 40-75)
* Informed consent to study investigations
* Ability to read and write Danish AND (only at-risk patients)
* Prior or current alcohol overuse, defined as an average intake of ≥24 grams/day (14 units/week) for women and ≥36 grams/day (21 units/week) for men, for at least 5 years; OR
* Presence of the metabolic syndrome defined by central obesity plus any two of the following four metabolic risk factors: (a) raised triglycerides, (b) reduced HDL cholesterol, (c) raised blood pressure and (d) raised fasting plasma glucose;\[38\] OR
* Type 2 diabetes mellitus defined by either fasting plasma glucose ≥7 mmol/L, HbA1c ≥48 mmol/mol, a random plasma glucose ≥11.1 mmol/L in the presence of classic diabetes or an oral glucose tolerance test with fasting plasma glucose ≥7.0 mmol/L and/or 2 hour plasma glucose ≥11.1 mmol/L.

EXCLUSION CRITERIA

We will exclude patients from screening in case of:

* Evidence of decompensated liver disease, defined by clinically obvious ascites, overt hepatic encephalopathy, jaundice or large esophageal varices with/without variceal bleeding.
* Known concurrent liver disease other than ALD and NAFLD.
* Cancer or other debilitating disease with an expected survival of less than 12 months.
* Inability to comply with the study protocol.

In screened patients with liver stiffness ≥8 kPa we will abstain from a liver biopsy in case of:

* Contraindications for a percutaneous liver biopsy
* Severe alcoholic hepatitis or other hepatic inflammation evidenced by transaminase elevation of more than three times the upper limit of normal.
* Hepatic congestion or bile duct dilation evidenced by ultrasound.
* Decrease of TE below 6.0 kPa from screening to time of planned liver biopsy.

Where it's running

• Department of Gastroenterology and Hepatology, Odense University Hospital
  Odense, Denmark Recruiting

Study contacts

• Principal investigator: Maja Thiele, MD, PhD, Professor — Department of Gastroenterology and Hepatology, Odense University Hospital
• Study coordinator: Maja Thiele, MD, PhD, Professor
• Email: maja.thiele@rsyd.dk
• Phone: +4524998068

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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.