Chronic Liver Injury, Mindray Hepatus 9 Ultrasound Diagnostic System
Conditions
Brief 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.
Interventions
OTHERVisual Transient Elastography (ViTE) Examination
Post-marketing product (Mindray Hepatus 9 Ultrasound Diagnostic System) for visual transient elastography examination in patients with liver injury.
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shenzhen Mindray Bio-Medical Electronics Co., Ltd
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
China
Contacts
CONTACTChao Sun, PhD
Outcome results
None listed