Evaluation of Agreement Between the Handheld Elastography Device and iLivTouch for Multi-Position Liver Assessment in Chronic Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 224
- 主要终点
- Agreement Between the Handheld Elastography Device and iLivTouch for Liver LSM in the Supine Position
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Agreement Between the Handheld Elastography Device and iLivTouch for Liver LSM in the Supine Position
时间窗: At the time of liver elastography assessment (baseline)
次要结局
- Agreement Between Devices in the Sitting Position(At baseline)
- Agreement Between Supine and Sitting Measurements (Handheld Device)(At baseline)
- ICC for LSM and UAP in the Supine Position(At baseline)
- Categorical Agreement in Fibrosis Staging and Steatosis Grading(At baseline)
研究者
Hong You
Principal Investigator
Beijing Friendship Hospital