Quantitative Ultrasound for Diagnosing Hepatic Steatosis in Nonalcoholic Fatty Liver Multicenter Study

Seoul National University Hospital112 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

112

Conditions

Diagnoses Disease

Interventions

Quantitative ultrasound (QUS) techniqueDIAGNOSTIC_TEST

Measurement of quantitative ultrasound parameter using clinical US machine (RS85)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Diagnostic performance of quantitative ultrasound parameters for diagnosing hepatic steatosis (S1)

Evaluation of area under the ROC curve (AUC) for the detection of fatty liver (S1)(reference standard: pathologic result)

Time frame: 1 month

Secondary Outcomes

Diagnostic performance of quantitative ultrasound parameters for diagnosing hepatic steatosis (S2 and S3)

Evaluation of area under the ROC curve (AUC) for the detection of fatty liver (S2 and S3)(reference standard: pathologic result)

Time frame: 1 month

Diagnostic performance of quantitative ultrasound parameters for diagnosing nonalcoholic steatohepatitis (NASH)

Evaluation of area under the ROC curve (AUC) for the detection of nonalcoholic steatohepatitis (reference standard: pathologic result)

Time frame: 1 month

Central Contacts

Jeong Min Lee, MD

CONTACT

02-2072-3107 jmlshy2000@gmail.com

Data from ClinicalTrials.gov

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