Examining liver inflammation in patients with non-alcoholic steatohepatitis

Characterization of the Intrahepatic Inflammatory Microenvironment in Patients With Non-alcoholic Steatohepatitis by Transcriptomics, Immunophenotyping and Functional Proteomics: Profil-NASH

This study is trying to see if examining liver inflammation in people with non-alcoholic steatohepatitis can help identify those at risk for serious liver problems.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hospices Civils de Lyon (Academic / other)
• Locations: 1 site (Lyon, Auvergne-Rhône-Alpes)
• Trial ID: NCT06152250 on ClinicalTrials.gov

What this trial studies

This study focuses on characterizing the intrahepatic inflammatory microenvironment in patients diagnosed with non-alcoholic steatohepatitis (NASH), a severe form of non-alcoholic fatty liver disease (NAFLD). It aims to identify patients with NASH who are at risk of developing fibrosis and hepatocellular carcinoma (HCC) by utilizing liver fine-needle aspiration for detailed analysis. The study will include patients with significant liver fibrosis and will exclude those with decompensated cirrhosis or secondary causes of liver disease. By understanding the inflammatory processes involved, the study seeks to improve patient management and access to therapeutic trials.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with non-alcoholic fatty liver disease and significant liver fibrosis.

Not a fit: Patients with decompensated cirrhosis or secondary causes of liver disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better identification and management of patients at risk for severe liver complications.

How similar studies have performed: While few studies have been conducted in humans, the approach of examining intrahepatic inflammation in NASH is gaining interest and may provide novel insights.

Eligibility criteria

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).

Where this trial is running

Lyon, Auvergne-Rhône-Alpes

• Service Hepato Gastrologie — Lyon, Auvergne-Rhône-Alpes, France (Recruiting)

Study contacts

• Study coordinator: Yasmina CHOUIK, MD

Conditions Liver Diseases; intra-hepatic immune responses; liver inflammation; non-alcoholic fatty liver; Non-alcoholic fatty liver disease