Liver Stiffness Changes by iLivTouch to Predict Liver-Related Events in MAFLD
ConditionMAFLD
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBeijing Friendship Hospital
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
This trial does not accept healthy volunteersQualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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 yearsSecondary outcomes
1
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 years2
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 years3
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 years4
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 yearsLocations
Sponsors and contacts
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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
Source ClinicalTrials.gov
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