Multicenter Clinical Study on Noninvasive Assessment of Hepatic Steatosis and Fibrosis Using Visual Transient Elastography
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 225
- 试验地点
- 2
- 主要终点
- The diagnostic performance of LiSA and ViTE was evaluated using the area under the receiver operating characteristic curve (AUROC).
研究概览
简要总结
Using liver biopsy as the gold standard, this study will conduct visual transient elastography (ViTE) examinations using Mindray Hepatus 9 ultrasound diagnostic system in patients with liver injury to evaluate the diagnostic efficacy of Liver Steatosis Analysis (LiSA) and ViTE for grading hepatic steatosis and fibrosis, and establish corresponding diagnostic thresholds.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be aged 18-65 years.
- •Documented liver injury of any etiology with a liver biopsy performed within the past 2 weeks.
- •Willing to undergo Visual Transient Elastography (ViTE) examination using Mindray Hepatus 9 Ultrasound System and capable of providing written informed consent.
排除标准
- •Acute viral hepatitis.
- •Right heart failure with either:Serum transaminases >5× upper limit of normal (ULN),Total bilirubin >85.5 μmol/L.
- •History of hepatocellular carcinoma (HCC).
- •Pregnancy.
- •Patients with implantable medical devices.
结局指标
主要结局
The diagnostic performance of LiSA and ViTE was evaluated using the area under the receiver operating characteristic curve (AUROC).
时间窗: baseline
Optimal cutoff values for LiSA and ViTE were determined by maximizing the Youden index, sensitivity (Se), and specificity (Sp). For each cutoff value, the following metrics with 95% confidence intervals (CI) were calculated: sensitivity (Se), specificity (Sp), positive predictive value (PPV), and negative predictive value (NPV).
次要结局
未报告次要终点