Quantitative US for Evaluation of Hepatic Steatosis in NAFLD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

173 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-03

Study Completion Date

2021-06-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Fatty Liver Fatty Liver, Nonalcoholic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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quantitative ultrasound imaging parameters

quantitative ultrasound imaging parameters

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

Group Type EXPERIMENTAL

Quantitative US (Samsung Medison, RS85A)

Intervention Type DIAGNOSTIC_TEST

In each patients, measurements of tissue attenuation imagine (TAI), tissue scatter-distribution imaging (TSI) parameters, hepatorenal index (EzHRI) will be performed

Interventions

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Quantitative US (Samsung Medison, RS85A)

In each patients, measurements of tissue attenuation imagine (TAI), tissue scatter-distribution imaging (TSI) parameters, hepatorenal index (EzHRI) will be performed

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes