NCT04985188Unknown不适用
Quantitative Ultrasound Imaging Parameters for Hepatic Steatosis in Patients With Non-alcoholic Fatty Liver Disease: Multicenter Prospective Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 112
- 主要终点
- Diagnostic performance of quantitative ultrasound parameters for diagnosing hepatic steatosis (S1)
研究概览
简要总结
To evaluate the diagnostic performance of quantitative ultrasound parameters for assessing hepatic steatosis in non-alcoholic fatty liver disease using histologic results as reference standard
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Clinically suspected or proven nonalcoholic fatty liver disease (NAFLD)
- •Patients who are scheduled hepatic parenchymal biopsy for suspected liver disease or hepatectomy for living donor liver donation
- •aged ≥ 18 years who are willing and able to complete all procedures
排除标准
- •excessive alcohol consumption within 2 years (40g/day for men, 20g/day for women)
- •clinical, laboratory, or histologic evidence of a liver disease other than NAFLD, including viral hepatitis, autoimmune hepatitis, or genetic or acquired disorders
- •use of steatogenic or hepatotoxic medication
- •evidence of decompensated liver disease
- •history of liver surgery
- •any other condition believed by investigator to affect a patients' compliance, or completion of the study
结局指标
主要结局
Diagnostic performance of quantitative ultrasound parameters for diagnosing hepatic steatosis (S1)
时间窗: 1 month
Evaluation of area under the ROC curve (AUC) for the detection of fatty liver (S1)(reference standard: pathologic result)
次要结局
- Diagnostic performance of quantitative ultrasound parameters for diagnosing nonalcoholic steatohepatitis (NASH)(1 month)
- Diagnostic performance of quantitative ultrasound parameters for diagnosing hepatic steatosis (S2 and S3)(1 month)
研究者
Jeong Min Lee
Professor
Seoul National University Hospital
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