Quantitative Ultrasound for Diagnosing Hepatic Steatosis in Nonalcoholic Fatty Liver Multicenter Study
- Conditions
- Diagnoses Disease
- Registration Number
- NCT04985188
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
To evaluate the diagnostic performance of quantitative ultrasound parameters for assessing hepatic steatosis in non-alcoholic fatty liver disease using histologic results as reference standard
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 112
Inclusion Criteria
- Clinically suspected or proven nonalcoholic fatty liver disease (NAFLD)
- Patients who are scheduled hepatic parenchymal biopsy for suspected liver disease or hepatectomy for living donor liver donation
- aged ≥ 18 years who are willing and able to complete all procedures
Exclusion Criteria
- excessive alcohol consumption within 2 years (40g/day for men, 20g/day for women)
- clinical, laboratory, or histologic evidence of a liver disease other than NAFLD, including viral hepatitis, autoimmune hepatitis, or genetic or acquired disorders
- use of steatogenic or hepatotoxic medication
- evidence of decompensated liver disease
- history of liver surgery
- any other condition believed by investigator to affect a patients' compliance, or completion of the study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diagnostic performance of quantitative ultrasound parameters for diagnosing hepatic steatosis (S1) 1 month Evaluation of area under the ROC curve (AUC) for the detection of fatty liver (S1)(reference standard: pathologic result)
- Secondary Outcome Measures
Name Time Method Diagnostic performance of quantitative ultrasound parameters for diagnosing nonalcoholic steatohepatitis (NASH) 1 month Evaluation of area under the ROC curve (AUC) for the detection of nonalcoholic steatohepatitis (reference standard: pathologic result)
Diagnostic performance of quantitative ultrasound parameters for diagnosing hepatic steatosis (S2 and S3) 1 month Evaluation of area under the ROC curve (AUC) for the detection of fatty liver (S2 and S3)(reference standard: pathologic result)