About this trial
This is an observational study (multicenter retrospective real-world cohort study). The purpose of this study is to assess the predictive performance of liver stiffness measurement (LSM, including baseline LSM1, current LSMC and their dynamic changes) acquired by domestic iLivTouch device for liver-related events (LREs) and all-cause mortality among MAFLD patients with compensated advanced chronic liver disease (cACLD), and to explore the prognostic value of dynamic LSM changes. The study population consists of adult patients aged ≥18 years of either sex, clinically diagnosed with MAFLD-related cACLD (defined as baseline LSM1 ≥10 kPa per Baveno-VII consensus), with at least two LSM measurements separated by ≥12-month follow-up interval, and without other confounding chronic liver diseases, excessive alcohol intake or predefined exclusion comorbidities. This study aims to answer several major questions: whether dynamic LSM parameters measured by iLivTouch can predict LREs and all-cause mortality in MAFLD-cACLD patients; whether risk of LREs differs between patients with significant LSMC decline and those without such decline in the resolved cACLD subgroup; whether liver-related mortality differs between resolved and persistent cACLD patients; and whether pharmacological interventions influence LRE risk and cACLD resolution.
Eligibility criteria
Qualifiers
Aged ≥18 years, both male and female.
Clinically diagnosed with Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD) and progressed to compensated advanced chronic liver disease (cACLD) according to the 2024 Chinese Guidelines for the Management of Metabolic-Associated (Non-Alcoholic) Fatty Liver Disease. cACLD is defined as baseline liver stiffness measurement (LSM1) ≥10 kPa based on the Baveno-VII consensus.
At least two valid LSM measurements during follow-up, with an interval of no less than 12 months between the two measurements.
Disqualifiers
Co-existing other chronic liver diseases, including viral hepatitis, drug-induced liver injury, autoimmune liver disease, etc.
Weekly alcohol intake ≥210 g for men or ≥140 g for women.
Occurrence of liver-related endpoint events within 6 months before or after obtaining the LSMC value.
Hepatectomy or liver transplantation performed within 6 months before or after obtaining the LSMC value.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Locations
Sponsors and collaborators
Beijing Friendship Hospital
Lead sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Collaborator
Guangzhou First People's Hospital
Collaborator
First Hospital of China Medical University
Collaborator
Panzhihua Central Hospital
Collaborator