Study of Liver Fine-Needle Aspiration to Explore Inflammation in Adults With Non-alcoholic Steatohepatitis and Non-alcoholic Fatty Liver Disease

What this Trial Is About

Non-alcoholic fatty liver disease NAFLD includes non-alcoholic fatty liver NAFL and non-alcoholic steatohepatitis NASH. NASH differs from NAFL by having liver inflammation and carries risks of progressing to cirrhosis and liver cancer. This condition affects about 25% of adults worldwide, with around 25% of NAFLD patients having NASH. Identifying NASH patients is important for monitoring liver damage and access to treatment trials, but human studies on liver inflammation in NASH are limited. This study involves patients undergoing routine liver biopsy to also receive fine-needle aspiration FNA and blood sampling to gather liver and immune cells. Forty patients will participate, with about 75% expected to have NASH and 25% NAFL. Researchers will analyze inflammatory cells using advanced techniques like RNA sequencing and immunophenotyping. Blood cells and circulating microRNAs will also be studied to understand immune regulation. Participants will undergo FNA and blood collection at the time of their liver biopsy, with clinical data recorded electronically. They will be monitored after the procedure as per standard care, with no additional follow-up required by the study. The main outcomes compare inflammatory cell profiles and molecular data between NAFL and NASH patients, plus analysis related to liver fibrosis severity, to better understand inflammations role in disease progression.

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