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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
NameTimeMethod
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
NameTimeMethod
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)

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