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

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.

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Key information

Conditions

MAFLD

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.
Malignant neoplasm diagnosed within 6 months before or after obtaining the LSMC value.
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.
History of transjugular intrahepatic portosystemic shunt (TIPS).
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.
Missing value of either LSM1 or LSMC.
Any other conditions judged by investigators to be inappropriate for study participation.

Treatment and study plan

Primary outcomes

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

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

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.

Secondary outcomes

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

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

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

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

Competing-risk regression model will be used to compare liver-related mortality risk between patients with resolved cACLD and patients with persistent cACLD.
Association between pharmacological interventions and risk of LREs among cACLD patients

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

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.
Association between pharmacological interventions and cACLD resolution

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

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

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Collaborators

First Hospital of China Medical University
Guangzhou First People's Hospital
Panzhihua Central Hospital
Third Affiliated Hospital, Sun Yat-Sen University

Registry information

Official study title

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

Acronym: MAFLD

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Aug 20, 2026
Registry last updated: Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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