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

Launched by MAJA THIELE · Oct 11, 2017

Keywords

ClinConnect Summary

This clinical trial is being conducted at Odense University Hospital to find better ways to detect advanced liver fibrosis, which is a serious condition where the liver becomes scarred. The study will use non-invasive methods, like ultrasound and blood tests, to see how well they can identify patients who are at risk for liver diseases, such as non-alcoholic fatty liver disease and alcoholic fatty liver disease. There will also be a control group of participants from the general population for comparison.

To be eligible for this trial, participants should be between the ages of 30 and 75, and if they are part of the general population group, they should be aged 40 to 75. Potential participants need to have a history of heavy alcohol use or certain health conditions like metabolic syndrome or type 2 diabetes. Those who join the study can expect to undergo screening tests to assess their liver health, without the need for invasive procedures like liver biopsies unless absolutely necessary. It’s important for interested individuals to understand that the study aims to improve how we detect liver problems early, which can lead to better treatment options.

Gender

ALL

Eligibility criteria

• • 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.