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

NCT07777198 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2303

Last updated 2026-08-20

No results posted yet for this study

Summary

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.

Conditions

  • MAFLD

Sponsors & Collaborators

  • Third Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Guangzhou First People's Hospital

    collaborator OTHER

  • First Hospital of China Medical University

    collaborator OTHER

  • Panzhihua Central Hospital

    collaborator OTHER

  • Beijing Friendship Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-17
Primary Completion
2027-10-16
Completion
2027-10-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07777198 on ClinicalTrials.gov