Automated Screening for Advanced Liver Fibrosis in Metabolic Liver Disease Using Routine Laboratory Data in Primary Care The LiverSeek Program

What this Trial Is About

Researchers are evaluating an automated, passive case-finding program called LiverSeek for detecting advanced liver fibrosis linked to metabolic dysfunction-associated steatotic liver disease MASLD in primary care. This program targets high-risk patients aged 50 to 75 years with specific metabolic risk profiles. LiverSeek aims to improve liver fibrosis screening rates by automatically using routine blood test data without adding workload to primary care providers. The study also compares different diagnostic methods and assesses health economic impacts. The LiverSeek program operates by automatically calculating the FIB-4 score from routine blood tests in eligible patients. If FIB-4 is above 1.30, two additional tests, ELF and MASEF, are reflexively ordered from the same serum sample without clinician intervention. Patients with positive second-step results are then referred to a Hepatology Advanced Practice Nurse for further evaluation including FibroScan VCTE and clinical assessment. A subset of patients may receive liver biopsy for detailed histological analysis. Additionally, a lifestyle intervention sub-study provides a personalized, nurse-led program for patients with positive non-invasive tests. Participants are identified through routine blood tests ordered by primary care in affiliated centers. Those with positive tests undergo clinical assessments, imaging, and questionnaires regarding health status and diet. Data is collected securely and pseudonymized. The study measures liver fibrosis prevalence within three months of the blood test and compares diagnostic accuracy of different non-invasive test combinations. Cost-effectiveness of the automated approach versus standard care is evaluated at study completion. Monitoring and reassessment occur over months, with total participation lasting until study end in 2027.

Automated Passive Case-Finding for Advanced Liver Fibrosis in MASLD: The LiverSeek Programme