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

Exploring the Risk Prediction of Liver-Related Events in Metabolic-Associated Fatty Liver Disease Based on Changes in Liver Stiffness Values Measured by iLivTouch

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 Overview

• Status: Not yet recruiting
• Conditions: MAFLD

• Study Type: Observational
• Enrollment (Estimated): 2303

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Multicenter retrospective real-world cohort of adult patients (≥18 years) with MAFLD-related compensated advanced chronic liver disease (cACLD, LSM1 ≥10 kPa per Baveno-VII consensus). Participants must have at least two LSM measurements ≥12 months apart. Patients with competing chronic liver diseases, excessive alcohol consumption, malignancies, TIPS history, acute liver injury and other predefined conditions are excluded from this study.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	From baseline LSM1 until documented cACLD resolution, loss to follow-up, or study end, up to 10 years

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Collaborators: Guangzhou First People's Hospital; Third Affiliated Hospital, Sun Yat-Sen University; First Hospital of China Medical University; Panzhihua Central Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 17, 2026
• Primary Completion (Estimated): October 16, 2027
• Study Completion (Estimated): October 30, 2027

Study Registration Dates

• First Submitted: August 17, 2026
• First Submitted That Met QC Criteria: August 17, 2026
• First Posted (Actual): August 20, 2026

Study Record Updates

• Last Update Posted (Actual): August 20, 2026
• Last Update Submitted That Met QC Criteria: August 17, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: liver stiffness measurement; Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD); Compensated Advanced Chronic Liver Disease (cACLD); liver-related events
• Other Study ID Numbers: 2026-P2-406-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No