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

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) - willing to sign a consent form 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. Always talk to your doctor about whether this trial is right for you.