Liver Pathology
Conditions
Keywords
Cirrhosis, Liver, Hepatic Cirrhosis, Liver Fibrosis, Fibrosis
Brief summary
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
Detailed 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
Interventions
DIAGNOSTIC_TESTTROD (rapid diagnostic orientation test) and FibroScan®
Fast-track appointment at the hepatology consultation at Avicenne Hospital (Bobigny) or the hepatology consultation at Jean Verdier Hospital (Bondy) for any patient : * with Fibroscan® ≥ 9.6 KPa or * positive hepatitis C serology or * HBsAg positive
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence of significant hepatic fibrosis in the general population of Seine Saint Denis | Two year of inclusion period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chronic hepatitis B prevalence | Two year of inclusion period | — |
| Chronic hepatitis C prevalence | Two year of inclusion period | — |
| Proportion of eligible patients for management of viral hepatitis B and C | Two year of inclusion period | Proportion of eligible patients for management of viral hepatitis B and C |
| Prevalence of other causes of chronic liver disease (alcohol and NASH) | Two year of inclusion period | — |
| Proportion of patients managed in hepatology department after screening for significant fibrosis | Two year of inclusion period | — |
| Prevalence of confirmed significant liver fibrosis in patients referred to hepatology consultation | Two years of inclusion period | This criterion will be assessed based on follow-up FibroScan results, non-invasive fibrosis blood tests, and/or liver biopsy when indicated, in accordance with current hepatology guidelines. |
| Proportion of patients with ultrasound signs of cirrhosis and hepatocellular carcinoma among patients referred to hepatology consultation (managed according to current hepatology guidelines). | Two years of inclusion period | This criterion will be assessed based on abdominal ultrasound findings according to current hepatology guidelines. |
Countries
France
Contacts
CONTACTVeronique GRANDO, MD-PhD
Outcome results
None listed