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.
Study Type
OBSERVATIONAL
Enrollment
225
Post-marketing product (Mindray Hepatus 9 Ultrasound Diagnostic System) for visual transient elastography examination in patients with liver injury.
XinHua Hospital Affiliated To Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGThe diagnostic performance of LiSA and ViTE was evaluated using the area under the receiver operating characteristic curve (AUROC).
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).
Time frame: baseline
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