Status:
RECRUITING
Characterization of the Intrahepatic Inflammatory Microenvironment in Patients With Non-alcoholic Steatohepatitis
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Liver Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Non-alcoholic fatty liver disease (NAFLD) is a nosological entity that groups together non-alcoholic fatty liver (NAFL) and non-alcoholic steatohepatitis (NASH). Unlike NAFL, NASH is characterized by ...
Eligibility Criteria
Inclusion
- patient with a clinical diagnosis of NAFLD: steatosis detected on imaging and exclusion of secondary causes of steatosis (drugs, genetics, alcohol consumption \>30 g/d in men and 20 g/d in women, chronic viral infection), in the absence or presence of an associated metabolic syndrome
- and with significant liver fibrosis (≥ F2) on at least one non-invasive test (FibroScan®, Fibrometer®, NAFLD Fibrosis Score);
- Patient of legal age (age ≥ 18 years);
- Patient willing to undergo liver biopsy ;
- Patient consenting to inclusion in the study after being informed and obtaining written consent;
- Patient affiliated to a social security scheme.
Exclusion
- Decompensated cirrhosis or clinically significant portal hypertension (clinical, radiological or endoscopic signs of portal hypertension; presence of hepatocellular insufficiency);
- Secondary causes of steatosis, including chronic viral hepatitis, drugs, excessive alcohol consumption according to World Health Organization (WHO) criteria (\> 30 g/d in men and 20 g/d in women), genetic mutations;
- Any other cause of liver disease: genetic hemochromatosis, autoimmune liver disease, etc. (non-exhaustive list);
- Presence of HCC at the time of inclusion;
- Contraindications to liver biopsy (identical to those for FNA): coagulation disorders, biliary tract dilatation, intrahepatic tumor;
- Pregnant, parturient or breast-feeding women;
- Persons deprived of their liberty by judicial or administrative decision;
- adults under legal protection (guardianship, curators).
Key Trial Info
Start Date :
January 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 29 2029
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06152250
Start Date
January 29 2023
End Date
January 29 2029
Last Update
September 18 2025
Active Locations (1)
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1
Service Hepato Gastrologie
Lyon, Auvergne-Rhône-Alpes, France, 69004