Screening tests for scarring of the liver in people at risk
Tests liver scarring screening tools in adults at risk of fatty liver disease.
Plain-language title generated from the registry record
Registry title: Screening At-risk Populations for Hepatic Fibrosis With Non-invasive Markers
Key facts
- Where
- Odense, DenmarkSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 30 and 75 years old?
Source: NCT03308916, who can take part
Where in Denmark
- Department of Gastroenterology and Hepatology, Odense University HospitalOdense, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Maja Thiele
- Trial code
- NCT03308916
- Record updated
- 1 September 2022
- Original description
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.Read full original descriptionShow less
Screening At-risk Populations for Hepatic Fibrosis With Non-invasive Markers
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.
Inclusion: 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: Known concurrent liver disease other than ALD and NAFLD; 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; Severe alcoholic hepatitis or other hepatic inflammation evidenced by transaminase elevation of more than three times the upper limit of normal; 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.