Linking Surrogate Endpoints to Long-term Final Outcomes in MASLD/MASH: A Korean Multicentre Real-World Evidence Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Occurrence of decompensated cirrhosis
研究概览
简要总结
This retrospective multicentre cohort study will use existing medical records from adults with Metabolic Dysfunction-Associated Steatotic Liver Disease or Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH) who underwent two Vibration-Controlled Transient Elastography-Liver Stiffness Measurement (VCTE-LSM) (FibroScan) assessments during routine clinical care. The study will evaluate whether changes in fibrosis risk tier between the two assessments are associated with future major liver-related outcomes and all-cause mortality. The duration of study will be 5 months.
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
- •Adults aged 18 years or older at the cohort entry date.
- •At least two VCTE examinations during the data period, with the interval between the first and second VCTE between 1 year and 5 years (both inclusive).
- •Diagnosis of MASLD, defined as the coexistence of hepatic steatosis confirmed by histology, imaging, or VCTE-Controlled Attenuation Parameter (CAP) more than or equal to (≥) 248 decibels per meter (dB/m), and at least one cardiometabolic criterion, in accordance with the Multi-society MASLD nomenclature consensus.
排除标准
- •Prior history of hepatocellular carcinoma at any time before index date.
- •Prior history of decompensated cirrhosis (any of: bleeding oesophageal varices, ascites, hepatic encephalopathy, hepatorenal syndrome) at any time before index date.
- •Prior history of liver resection or transplantation at any time before index date.
- •Prior diagnosis of any extrahepatic malignancy at any time before index date.
- •Occurrence of any MALO component (HCC, complication of liver cirrhosis, liver transplantation, or death) within 6 months after the index date.
- •Antiviral treatment for hepatitis B or hepatitis C virus initiated more than 3 months before the index date and ongoing through the index date.
- •Total post-index follow-up duration of less than 6 months.
- •Insufficient medical record data preventing operationalisation of key study variables.
结局指标
主要结局
Occurrence of decompensated cirrhosis
时间窗: From index date (second VCTE and start of follow-up) to the first occurrence of major adverse liver outcome (MALO) (up to 31 Dec 2025)
Confirmed by referring to histology, imaging (e.g., abdominal ultrasound, computed tomography, or magnetic resonance imaging) reports. Primary endpoint will be presented with composite outcome.
Occurrence of hepatocellular carcinoma (HCC) confirmed by imaging or biopsy
时间窗: From index date (second VCTE and start of follow-up) to the first occurrence of MALO (up to 31 Dec 2025)
Confirmed by imaging or histological confirmation in the medical record. Primary endpoint will be presented with composite outcome.
Liver transplantation
时间窗: From index date (second VCTE and start of follow-up) to the first occurrence of MALO (up to 31 Dec 2025)
Operationalised as liver transplantation, identified by transplant procedure code or EMR documentation. Chronic liver failure not requiring transplantation is not separately ascertained and is captured within the decompensated-cirrhosis component. Primary endpoint will be presented with composite outcome.
All-cause death
时间窗: From index date (second VCTE and start of follow-up) to the first occurrence of MALO (up to 31 Dec 2025)
Documented in the EMR or via linkage to administrative records where available. Primary endpoint will be presented with composite outcome.
次要结局
未报告次要终点