Comparing Two Non-Invasive Methods to Diagnose Advanced Liver Fibrosis in NAFLD Patients

What this Trial Is About

Non-Alcoholic Fatty Liver Disease NAFLD, which is linked to overweight and insulin resistance, affects about 25% of the global population. Identifying advanced liver fibrosis ALF in NAFLD is important because it marks patients with a higher risk of liver-related complications who need special care. While liver biopsy is the standard for diagnosing liver fibrosis, it is invasive and not suitable for routine use. Non-invasive tests like liver stiffness measurement LSM with Fibroscan and blood fibrosis tests are available, but each has limitations in accuracy, cost, and accessibility. Two combined diagnostic algorithms, FIB4-Fibroscan FIB4-FS and eLIFT-FibroMeterVCTE eLIFT-FMVCTE, have been developed to improve diagnosis by sequentially using simple blood tests followed by more precise tests, reserving biopsy for unclear cases. This trial compares these two strategies for diagnosing ALF in NAFLD patients. Participants will be assessed using a single diagnostic approach involving the FIB4-FS and eLIFT-FMVCTE algorithms. Patients are divided into two groups a low-risk group without metabolic syndrome or elevated AST levels, where liver biopsy is generally not required, and an at-risk group with metabolic syndrome or higher AST, who will undergo liver biopsy alongside clinical data collection, blood sampling, and Fibroscan on the same day. This design aims to validate and compare the accuracy and clinical usefulness of both algorithms in an independent patient group. During the study, participants will have clinical data recorded, blood samples taken, and liver stiffness measured with Fibroscan. Those in the at-risk group will also have a liver biopsy. Researchers will track how accurately each strategy classifies advanced liver fibrosis, including sensitivity and factors affecting diagnostic performance. The main outcome is the rate of correct diagnosis of advanced fibrosis within two months. Safety and other secondary outcomes related to diagnostic accuracy will also be evaluated. Participation duration varies but assessments focus on the initial diagnostic period and follow-up at two months.

Comparison of Two sTRAtegies For the Non-Invasive Diagnosis of advanCed Liver Fibrosis in NAFLD