City-hospital Collaboration for the Early Screening of Hepatic Fibrosis in Primary Care: a Secondary Prevention Project in the Grenoble Health Basin

NCT ID: NCT07031089

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-02
• Study Completion Date: 2028-11-02

Brief Summary

Cirrhosis and hepatocellular carcinoma (HCC) are responsible for 25,000 deaths per year in France. The main causes are excessive alcohol consumption, metabolic steatosis, and hepatitis B and C. Fibrosis, classified from F0 (absence of fibrosis) to F4 (cirrhosis), is the sole determinant of liver-related mortality, particularly from stage F3. The incidence of metabolic steatosis is increasing, associated with a rise in mortality from chronic liver diseases (CLD). CLDs, often asymptomatic, are diagnosed late, reducing patient survival. Recommendations exist for the screening of hepatic fibrosis in at-risk patients (alcohol, diabetes, metabolic syndrome). This screening relies on calculating the FIB-4 score (calculated from widely prescribed variables: AST, ALT, platelets, age), followed by Fibroscan® (a non-invasive test for hepatic fibrosis) if FIB-4 > 1.3.

A Fibroscan® result <8kPa excludes advanced fibrosis, while a result >9.6kPa suggests advanced fibrosis and ≥15kPa indicates cirrhosis. The appropriate care pathway includes a risk reduction program, a specialized consultation for patients with Fibroscan® ≥8kPa, and semi-annual screening for HCC in the case of cirrhosis. Indeed, it has been shown in a French cohort of patients with viral C cirrhosis that adherence to semi-annual screening is associated with better survival.

Eligible patients are primarily seen in primary care, and INCA has published a recommendation intended for general practitioners to improve the screening of fibrosis [13]. However, FIB-4 is poorly known among general practitioners [14], and access to Fibroscan® remains limited [15], hindering the implementation of the recommendations. Therefore, a care pathway has been established in the Grenoble area, initiated by Professor Costentin, allowing access to Fibroscan® for patients in primary care, starting from 2022 at the CHU. The objective is to evaluate the completion of the pathway, particularly the management of MCF risk factors and referral to specialized consultation for patients with Fibroscan® ≥8 kPa.

Conditions

Liver Fibrosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Non-interventional study (RIPH category 3)

The study aims to describe and evaluate an existing care pathway, implemented within the framework of current clinical practice, without modifying the modalities of care or adding specific interventions. No additional procedures are imposed on participants, apart from data collection for evaluation purposes and telephone interviews.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients aged 18 years or older
• Having undergone a Fibroscan® at the CHU de Grenoble-Alpes , requested by a primary care practitioner (general practitioner, non-hospital diabetologist, Asalée nurse), as part of the screening recommendations for liver fibrosis in the case of a FIB4 score > 1.3
• With a result ≥ 8kPa
• Between January 2023 and January 2026

Exclusion Criteria

• Patients who have expressed their opposition to participating in the study
• Patients under guardianship or deprived of liberty
• Patients with a known chronic liver disease who are being monitored at the time of the Fibroscan® procedure

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2025-A010187-42

Identifier Type: -

Identifier Source: org_study_id