Screening of Patients With Hepatic Fibrosis or Cirrhosis B and C (DEP-CB)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Liver Pathology

Treatments: Diagnostic Test: TROD (rapid diagnostic orientation test) and FibroScan®

Study type: Interventional

Funder types: Other

Identifiers

NCT06755632

APHP240250

Details and patient eligibility

About

Regardless of its etiology (chronic hepatitis B or C, alcohol consumption, metabolic steatohepatitis, hemochromatosis, autoimmune liver disease), cirrhosis is a real public health issue. Cirrhosis is a chronic disease and can get complicated by liver cancer, digestive hemorrhage, or liver failure, which are responsible for morbidity and mortality.

In France, cirrhosis prevalence is estimated at 700,000 patients and induce 16,000 deaths per year (10,000 liver cancer and 6,000 liver decompensation). In Ile-de-France area, cirrhosis prevalence is estimated at 130,000 cases, a lot of them are in Seine Saint Denis department due to precariousness.

Hepatitis C virus can now be cured and hepatitis B treatment can suspend hepatitis B replication. All these treatments reduce liver complications but even after virological cure, cirrhosis requires dedicated long term management as well as alcoholic liver disease and metabolic steatohepatitis at cirrhosis stage.

Periodic screening for complications and specific measures were defined by french HAS in 2007 (medication intake, dietary management and specific vaccinations), especially the performance of a semi-annual liver ultrasound for hepatocellular carcinoma (HCC) screening.

Then, it seems essential to screen for patients with viral hepatitis and extensive fibrosis or cirrhosis in our department to achieve active and individualized management of this chronic liver disease, to reduce long term morbidity and mortality.

The main aim of the study is to evaluate the prevalence of advanced liver fibrosis and viral infections B and C in the general population of Seine Saint Denis, using a dual screening method of TROD (rapid diagnostic orientation test) and FibroScan®, combined with a care pathway

Full description

Targeted population

The targeted population will be users of one municipal health center visiting the municipal health center on a given day We will propose a screening for liver fibrosis using Fibroscan mini® and will propose rapid diagnostic orientation tests (TROD) for HCV and HBV viral infection, by a traveling physician Expérimental scheme

Proposal by the caregiver to each patient at the center :

• Fibroscan®
• TROD VHC / VHB IF Fibroscan ≥ 9.6 KPa or positive HCV TROD or HBsAg positive THEN Suggested appointment Avicenne hospital hepatology consultation or Jean Verdier hepatology consultation

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age≥18 years
• Collection of signed consent
• Patients affiliated to a Social Security System

Exclusion criteria

• Pregnancy or breastfeeding
• Subjects under AME
• Persons under court protection
• Guardianship or curatorship,
• Safeguard of justice
• Persons under psychiatric care without their consent
• Persons admitted to a health or social institution for purposes other than research,
• Patients of full age under legal protection (guardianship or curatorship)
• Persons unable to express their consent.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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600 participants in 1 patient group

Patients of a municipal health center who visit the municipal health center on a given day.

Experimental group

Treatment:

Diagnostic Test: TROD (rapid diagnostic orientation test) and FibroScan®