Screening for Chronic Liver Diseases in General Population (HEPGEN)

University Hospital Center (CHU)

Status: Not yet enrolling

Conditions: Fibrosis, Liver

Treatments: Diagnostic Test: Blood sample then fibroscan

Study type: Interventional

Funder types: Other

Identifiers

NCT06366425

RECHMPL23_0272

Details and patient eligibility

About

Improving the care of patients with liver diseases in primary care and will allow patients with chronic liver disease to benefit from a course appropriate care.

Full description

The prevalence of chronic liver diseases continues to increase on the one hand by the increase in non-alcoholic fatty liver disease (NAFLD) which affects 25% of the general population as well as the increased incidence of hepatocellular carcinoma in recent years. Screening for liver fibrosis in the general population represents a major public health issue.

The FIB-4 score is obtained by a blood test. This score combines age, measurement of ALT/ASAT (alanine aminotransferase / aspartate-aminotransferase) and platelet count. This score is sensitive for detecting advanced fibrosis liver and allows 71% of patients to avoid a liver biopsy.

Transient elastometry (Fibroscan®) is another very effective non-invasive assessment in the diagnosis of chronic liver diseases and hepatic fibrosis. It has already been demonstrated by several studies that combining several non-invasive fibrosis tests allows to improve the precision of the result.

The investigators hypothesize that offering an additional assessment by Fibroscan for patients screened by a blood test (FIB-4 Score) as possibly having advanced liver fibrosis (Score >2.67) will raise awareness among professional practitioners and the general population with chronic liver diseases and refine screening for chronic liver diseases.

Enrollment: 260 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 40 years
• Without known liver pathologies
• Having at least one risk factor for chronic liver disease: risky consumption of alcoholic beverages according to the AUDIT questionnaire, the presence of metabolic syndrome, diabetes or a risk factor for viral hepatitis B, D or C.

Exclusion criteria

• Fibroscan already performed in the last 12 months
• Failure to collect express oral consent
• Patient not affiliated with or not benefiting from a national health insurance scheme
• Patient protected by law
• Patient under guardianship or curatorship
• Patient deprived of liberty
• Pregnant or breastfeeding woman

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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260 participants in 1 patient group

Population with a chronic liver disease risk factor

Other group

Description:

Patient aged ≥ 40 years, with no known liver disease, consulting a general practitioner and having at least one risk factor for chronic liver disease: risky consumption of alcoholic beverages according to the AUDIT questionnaire, the presence of a metabolic syndrome, diabetes or a risk factor for viral hepatitis B/D or C.

Treatment:

Diagnostic Test: Blood sample then fibroscan