Screening for Advanced Liver Fibrosis Using Non-invasive Tests in Primary Care

Study Overview
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Brief Summary
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Liver fibrosis screening is possible at the asymptomatic stage through a healthcare management strategy currently recommended for patients with risk factors for chronic liver disease. It is based on a sequential strategy involving a 1st-line test, fibrosis score calculation (FIB-4). Given this opportunity to identify advanced fibrosis in asymptomatic patients, the project aims to set up this screening program in the Grenoble area with Biogroup Laboratories, in collaboration with the Hepato-gastroenterology department (HGE) of Grenoble University Hospital. The aim of this study is to evaluate the success of sequential screening using FIB-4, followed by a specialized fibrosis test for the diagnosis of advanced hepatic fibrosis

Official Title
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Screening for Advanced Liver Fibrosis Using Non-invasive Tests in Primary Care

Conditions
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Hepatic Fibrosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between 18 and 75 years of age FIB-4 2.67 Patients covered by Health Insurance System Exclusion Criteria: Prescription triggering FIB-4 emanate from a hepatogastroenterologist or oncologist Conditions associated with high risk false-positive FIB-4: ASAT or ALAT > 300 IU/L, platelets <50 G/L or >500 G/L. Patient refusing to participate Subjects under guardianship or deprived of liberty

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the sequential screening of advanced hepatic fibrosis in primary care using an automatic calculation of FIB-4 followed by the use of a specialized non-invasive fibrosis test | Percentage of patients with advanced hepatic fibrosis (fibrosis at least equivalent to stage F3 or F4 according to METAVIR at the end of the evaluation by the hepatogastroenterologist) diagnosed among patients with no known HCV infection and FIB-4 ≥2.67 | up to 14 months | 
| Evaluation of diagnoses of advanced hepatic fibrosis made during the study compared to the expected disease frequency | Proportion of diagnoses made at 14 months to the expected disease frequency among patients with no known HCV infection and FIB-4 ≥2.67 | up to 14 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Among all patients with calculated FIB-4 scores, evaluate the proportion of patients eligible for a specialized hepatic fibrosis assessment test. | Proportion of patients with FIB-4 ≥2.67 among patients who underwent FIB-4 calculation or the screened population. | up to 12 months | 
| Evaluate, among patients with FIB-4 ≥2.67, the proportion of pathways compliant at 14 months. | Proportion among patients with FIB-4 ≥2.67 who have received appropriate medical care, defined by the performance of a specialized test and a specialist consultation if the test is positive. | up to 14 months | 
| Evaluate, among patients diagnosed with advanced fibrosis, the proportion of specialized follow-ups compliant with recommendations at 14 months. | Proportion among patients with advanced fibrosis who have had at least one specialist consultation, and for patients with cirrhosis, a semi-annual screening ultrasound for HCC within 14 months. | up to 14 months | 
| Description of social and clinical determinants associated with the diagnosis of advanced fibrosis and the quality of follow-up at 14 months | Estimation of crude and adjusted relative risks for advanced liver fibrosis and non-compliant follow-up associated with the following variables: age, sex, smoking, diabetes, obesity, sleep apnea syndrome, high blood pressure, dyslipidemia, alcohol consumption, screening for alcohol-related risks, physical activity, medical history, current treatments, level of education, socio-professional category, assessment of precariousness, existence of situations of non-use of healthcare | up to 14 months |