About this trial
This single-center cross-sectional study aims to evaluate the agreement between a handheld elastography device and the iLivTouch transient elastography system for the noninvasive assessment of liver fibrosis and steatosis in adults with chronic liver disease. The study compares liver stiffness measurement (LSM) and ultrasound attenuation parameter (UAP) obtained by both devices in the standard supine position, and further explores the feasibility and consistency of measurements performed in the sitting position.
All participants will undergo paired examinations using both devices in two body positions (supine and sitting). Agreement between devices and between body positions will be assessed using Bland-Altman analysis, intraclass correlation coefficients, and categorical consistency metrics. The study will also evaluate device performance indicators, including measurement success rate, procedure time, and battery endurance under simulated clinical conditions.
This study aims to provide clinical evidence on the accuracy, reliability, and feasibility of a new handheld transient elastography device, and to explore whether sitting-position measurements can serve as an alternative to standard supine assessment in chronic liver disease patients.
Eligibility criteria
Qualifiers
Adults aged 18 years or older.
Chronic hepatitis B or compensated HBV-related cirrhosis (based on the 2022 Chinese CHB guidelines), or
Metabolic dysfunction-associated fatty liver disease (MAFLD), metabolic dysfunction-associated steatohepatitis (MASH), or fibrosis/cirrhosis due to MAFLD (based on the 2024 MAFLD guidelines).
Willing and able to provide written informed consent.
Disqualifiers
Chronic liver disease due to other etiologies (e.g., other viral hepatitis, autoimmune liver disease, alcoholic liver disease, genetic/metabolic liver disease).
Evidence of decompensated cirrhosis.
Total bilirubin > 51 μmol/L.
ALT > 5 × upper normal limit.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Locations
Sponsors and collaborators
Hong You
Lead sponsor
Beijing Friendship Hospital
Sponsor institution