Screening At-risk Populations for Hepatic Fibrosis With Non-invasive Markers

Recruiting now · Not applicable

Conditions studied: Liver Diseases, Alcoholic, Fibrosis

In brief

Prospective screening study at Odense University Hospital to assess the effect of transient elastography and other serum and imaging markers of liver fibrosis to detect advanced fibrosis (Kleiner Fibrosis score F3-F4) in patients at risk of non-alcoholic fatty liver disease, alcoholic fatty liver disease, with a control group of participants recruited from the general population.

Key facts

Study ID

NCT03308916

Run by

Maja Thiele

People needed

6500

Starts

2017-10-06

Expected to finish

2035-10-30

Last updated by the study team

2022-09-01

Who can join

Age: 30 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Department of Gastroenterology and Hepatology, Odense University Hospital — Odense, Denmark (enrolling)

Full record on ClinicalTrials.gov

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