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

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-26
• Study First Submitted QC: 2021-07-26
• Last Update Submitted: 2021-07-26
• Study First Posted: 2021-08-02
• Last Update Posted: 2021-08-02
• Study Start: 2021-08-12
• Primary Completion: 2022-07-31
• Study Completion: 2022-12-31

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)