Exploring the Risk Prediction of Liver-Related Events in Metabolic-Associated Fatty Liver Disease Based on Changes in Liver Stiffness Values Measured by iLivTouch
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,303
- 主要终点
- Predictive performance of liver stiffness measurements (LSM1, LSMC and their dynamic changes) for liver-related events (LREs) and all-cause mortality
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •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.
排除标准
- •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.
- •Malignant neoplasm diagnosed within 6 months before or after obtaining the LSMC value.
- •Presence of vascular liver disease, cystic fibrosis-related liver disease, sarcoidosis, polycystic liver disease, congenital or rare inherited liver disease, mechanical cholestasis, secondary sclerosing cholangitis, or heart failure complicated by hepatic venous congestion.
- •History of transjugular intrahepatic portosystemic shunt (TIPS).
- •Acute hepatitis (alanine aminotransferase >5-fold upper limit of normal) or acute-on-chronic liver failure (ACLF) occurring at the time of LSM1 or LSMC measurement.
- •Missing value of either LSM1 or LSMC.
- •Any other conditions judged by investigators to be inappropriate for study participation.
结局指标
主要结局
Predictive performance of liver stiffness measurements (LSM1, LSMC and their dynamic changes) for liver-related events (LREs) and all-cause mortality
时间窗: 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 years
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.
次要结局
- Difference in risk of LREs between patients with significant LSMC decline versus non-significant LSMC decline within resolved cACLD subgroup(From baseline LSM1 until LRE occurrence, death, loss to follow-up, or study end, up to 10 years)
- Difference in liver-related mortality risk between resolved cACLD patients and persistent cACLD patients(From baseline LSM1 until liver-related death, death from other causes, loss to follow-up, or study end, up to 10 years)
- Association between pharmacological interventions and risk of LREs among cACLD patients(From baseline LSM1 until LRE occurrence, death, loss to follow-up, or study end, up to 10 years)
- Association between pharmacological interventions and cACLD resolution(From baseline LSM1 until documented cACLD resolution, loss to follow-up, or study end, up to 10 years)
研究者
Hong You
Chief Physician, Principal Investigator
Beijing Friendship Hospital