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

Prior treatment

• Known concurrent liver disease other than ALD and NAFLD.

Other illness

• Evidence of decompensated liver disease, defined by clinically obvious ascites, overt hepatic encephalopathy, jaundice or large esophageal varices with/without variceal bleeding.
• Cancer or other debilitating disease with an expected survival of less than 12 months.

Lab values

• Severe alcoholic hepatitis or other hepatic inflammation evidenced by transaminase elevation of more than three times the upper limit of normal.

Other

• We will exclude patients from screening in case of:
• 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
• Hepatic congestion or bile duct dilation evidenced by ultrasound.
• Decrease of TE below 6.0 kPa from screening to time of planned liver biopsy.

• 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.