Multicenter Clinical Study on Noninvasive Assessment of Hepatic Steatosis and Fibrosis Using Visual Transient Elastography

Condition(s) studied

Investigational drug(s) / intervention(s)

Visual Transient Elastography (ViTE) Examination: Post-marketing product (Mindray Hepatus 9 Ultrasound Diagnostic System) for visual transient elastography examination in patients with liver injury.

Study summary

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.

Eligibility

Primary outcome measure(s)

• The diagnostic performance of LiSA and ViTE was evaluated using the area under the receiver operating characteristic curve (AUROC). — 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).

Trial sites (1)

More Xinhua Hospital, Shanghai Jiao Tong University School of Medicine trials in China