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Characterization of the Intrahepatic Inflammatory Microenvironment in Patients With Non-alcoholic Steatohepatitis

RecruitingNAAges 18 Years - anyAllHospices Civils de Lyon
NCT06152250 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 intrahepatic inflammation, and is solely at risk of progression to cirrhosis and hepatocellular carcinoma (HCC). It is currently estimated that NAFLD affects approximately 25% of the world's adult population, and its incidence is rising in all regions of the world. Nevertheless, of all patients with NAFLD, only \~25% have NASH. Identifying patients with NASH is therefore crucial, determining the need for follow-up to detect the onset of fibrosis and/or HCC, and eventual access to therapeutic trials. Furthermore, intrahepatic inflammation, the initial driver of NASH, appears to play an important role in the development of fibrosis and HCC, which can occur in the absence of cirrhosis in thes

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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).
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What it tests

  • Liver Fine-Needle Aspiration
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Where

1 site
Service Hepato Gastrologie
Lyon, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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