Comparison of a Handheld Elastography Device With iLivTouch in Chronic Liver Disease Patients

N/ANot Yet RecruitingNCT07242404

Hong You224 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

224

Conditions

MAFLD HEPATITIS B CHRONIC

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults aged 18 years or older. * Diagnosed with one of the following: * 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. Exclusion Criteria: * 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. * Presence of hepatocellular carcinoma, hepatic hemangioma, large hepatic cyst, or other space-occupying liver lesions. * Co-infection with HIV. * History of liver transplantation or TIPS. * Pregnancy. * Congestive hepatopathy. * Unhealed wounds in the right upper abdomen. * Inability to maintain the required sitting position.

Outcomes

Primary Outcomes

Agreement Between the Handheld Elastography Device and iLivTouch for Liver LSM in the Supine Position

Time frame: At the time of liver elastography assessment (baseline)

Secondary Outcomes

ICC for LSM and UAP in the Supine Position

Time frame: At baseline

Categorical Agreement in Fibrosis Staging and Steatosis Grading

Time frame: At baseline

Agreement Between Devices in the Sitting Position

Time frame: At baseline

Agreement Between Supine and Sitting Measurements (Handheld Device)

Time frame: At baseline