Status:
RECRUITING
Screening At-risk Populations for Hepatic Fibrosis With Non-invasive Markers
Lead Sponsor:
Maja Thiele
Collaborating Sponsors:
Horizon 2020 - European Commission
Novo Nordisk A/S
Conditions:
Liver Diseases, Alcoholic
Fibrosis
Eligibility:
All Genders
30-75 years
Phase:
NA
Brief Summary
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 Fibr...
Detailed Description
This protocol describes a prospective screening study at Odense University Hospital, Department of Gastroenterology and Hepatology. The investigators will use liver stiffness measurements with transie...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2035
Estimated Enrollment :
6500 Patients enrolled
Trial Details
Trial ID
NCT03308916
Start Date
October 6 2017
End Date
October 30 2035
Last Update
September 1 2022
Active Locations (1)
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1
Department of Gastroenterology and Hepatology, Odense University Hospital
Odense, Denmark, 5000