Liver Stiffness Changes by iLivTouch to Predict Liver-Related Events in MAFLD

N/ANot Yet RecruitingNCT07777198

Beijing Friendship Hospital2,303 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

2,303

Conditions

MAFLD

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged ≥18 years, both male and female. 2. 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. 3. At least two valid LSM measurements during follow-up, with an interval of no less than 12 months between the two measurements. Exclusion Criteria: 1. Co-existing other chronic liver diseases, including viral hepatitis, drug-induced liver injury, autoimmune liver disease, etc. 2. Weekly alcohol intake ≥210 g for men or ≥140 g for women. 3. Occurrence of liver-related endpoint events within 6 months before or after obtaining the LSMC value. 4. Hepatectomy or liver transplantation performed within 6 months before or after obtaining the LSMC value. 5. Malignant neoplasm diagnosed within 6 months before or after obtaining the LSMC value. 6. Presence of vascular liver disease, cystic fibrosis-related liver disease, sarcoidosis, polycystic liver disease, congenital or rare inherited liver disease, mechanical cholestasis, secondary sclerosing cholangitis, or heart failure complicated by hepatic venous congestion. 7. History of transjugular intrahepatic portosystemic shunt (TIPS). 8. Acute hepatitis (alanine aminotransferase \>5-fold upper limit of normal) or acute-on-chronic liver failure (ACLF) occurring at the time of LSM1 or LSMC measurement. 9. Missing value of either LSM1 or LSMC. 10. Any other conditions judged by investigators to be inappropriate for study participation.

Outcomes

Primary Outcomes

Predictive performance of liver stiffness measurements (LSM1, LSMC and their dynamic changes) for liver-related events (LREs) and all-cause mortality

Area under the receiver operating characteristic curve (AUC) will be used to evaluate the predictive performance of baseline liver stiffness (LSM1), current liver stiffness (LSMC), and their dynamic changes for liver-related events (LREs) and all-cause mortality in patients with MAFLD-related cACLD.

Time frame: From the time of baseline LSM1 measurement until occurrence of LREs, death, loss to follow-up, or end-of-study cutoff, assessed up to 10 years

Secondary Outcomes

Difference in risk of LREs between patients with significant LSMC decline versus non-significant LSMC decline within resolved cACLD subgroup

Cox proportional-hazards model will be applied to compare the risk of liver-related events (LREs) between resolved cACLD patients with significant LSMC decline (≥20 % LSM reduction or LSMC \< 10 kPa) and those without significant LSMC decline.

Time frame: From baseline LSM1 until LRE occurrence, death, loss to follow-up, or study end, up to 10 years

Difference in liver-related mortality risk between resolved cACLD patients and persistent cACLD patients

Competing-risk regression model will be used to compare liver-related mortality risk between patients with resolved cACLD and patients with persistent cACLD.

Time frame: From baseline LSM1 until liver-related death, death from other causes, loss to follow-up, or study end, up to 10 years

Association between pharmacological interventions and risk of LREs among cACLD patients

Cox proportional-hazards model will be used to explore whether different pharmacological interventions are associated with significant differences in the risk of liver-related events (LREs) in cACLD patients.

Time frame: From baseline LSM1 until LRE occurrence, death, loss to follow-up, or study end, up to 10 years

Association between pharmacological interventions and cACLD resolution

Logistic regression model will be used to explore whether different pharmacological interventions are associated with significant differences in the probability of cACLD resolution.

Time frame: From baseline LSM1 until documented cACLD resolution, loss to follow-up, or study end, up to 10 years