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Diagnostic test of liver fibrosis in nonalcoholic fatty liver disease assessed by two-dimensional shear wave elastic imaging

Diagnostic test of liver fibrosis in nonalcoholic fatty liver disease assessed by two-dimensional shear wave elastic imaging

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400085360
Enrollment
Unknown
Registered
2024-06-05
Start date
2024-06-10
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metabolic associated fatty liver disease

Interventions

Gold Standard:According to the pathological staging results of the gold standard liver biopsy, the non-case group was defined as having no liver fibrosis (S0 stage), while the case group was defined a
Index test:2D-SWE GE Ultrasound Diagnostic Instrument a. Before the examination, the patient should fast for 2-3 hours and rest for 10 to 20 minutes. b. Instrument settings: The elastography sampling

Sponsors

The First Hospital of Jilin University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Patients suspected of having non-alcoholic fatty liver disease (NAFLD) (suggested by any imagingexamination) who voluntarily sian the informed consent form, 2.Undergo both two-dimensional shear wave elastography and transient elastography on the same day, 3.Undergo ultrasound-guided liver biopsy in our department; 4.Be at least 18 years old.

Exclusion criteria

Exclusion criteria: A history of alcohol consumption for more than 5 years, with male patients consuming =40g of alcohol per day and female patients =20g per day, or excessive alcohol consumption in the past two weeks, with male patients consuming =80g of alcohol per day and female patients =40g per day; Viral hepatitis, drug-induced liver injury, autoimmune hepatitis, or other diseases that cause secondary hepatic steatosis; Patients with contraindications for liver biopsy; Decompensated liver disease (defined as a Child-Pugh score > 7); Patients who have undergone liver transplantation or TIPS surgery; Patients with malignant liver lesions; Pregnant women or women who wish to become pregnant; Any other factors deemed by the researchers as unsuitable for inclusion or that may affect participation or completion of the study.

Design outcomes

Primary

MeasureTime frame
Liver stiffness measurement, LSM;Accuracy ;Sensitivity ;Specificity ;

Secondary

MeasureTime frame
Positive predicative value;Negative predictive value;

Countries

China

Contacts

Public ContactDezhi Zhang

The First Hospital of Jilin University

zhangdezhi1982@163.com+86 135 0440 2447

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026