Quantitative US for Evaluation of Hepatic Steatosis in NAFLD

Seoul National University

Status: Completed

Conditions: Fatty Liver; Fatty Liver, Nonalcoholic

Treatments: Diagnostic Test: Quantitative US (Samsung Medison, RS85A)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04462562

SNUH 2002-020-1099

Details and patient eligibility

About

The purpose of this study is to evaluate diagnostic performance of quantitative ultrasonographic parameters for the assessment of hepatic steatosis with find optimal cut-off values in patients with non-alcoholic fatty liver disease using magnetic resonance imaging proton density fat fraction (MRI-PDFF) and MR spectroscopy as the reference standard.

Enrollment: 173 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• patients with known NAFLD or suspected of having NAFLD
• Patients who are scheduled 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
• contraindication to MRI
• any other condition believed by investigator to affect a patients' compliance, or completion of the study

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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173 participants in 1 patient group

quantitative ultrasound imaging parameters

Experimental group

Description:

quantitative ultrasound imaging parameters * tissue attenuation imaging (TAI) parameter * tissue scatter-distribution imaging (TSI) parameter * Hepatorenal index (semi-auto, EzHRI)

Treatment:

Diagnostic Test: Quantitative US (Samsung Medison, RS85A)