๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 โฅ24 grams/day (14 units/week) for women and โฅ36 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 โฅ7 mmol/L, HbA1c โฅ48 mmol/mol, a random plasma glucose โฅ11.1 mmol/L in the presence of classic diabetes or an oral glucose tolerance test with fasting plasma glucose โฅ7.0 mmol/L and/or 2 hour plasma glucose โฅ11.1 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 โฅ8 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.
๐
What it tests
- transient elastography
- Enhanced liver fibrosis test
- Indirect serum markers of liver fibrosis
- Direct serum markers of liver fibrosis
- LiverTRAIL
Department of Gastroenterology and Hepatology, Odense University Hospital
Odense, Denmark
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.