Recruiting

Observational Study

Sponsor:

Tokyo Medical University

Code:

NCT04012242

Conditions

Nonalcoholic Steatohepatitis

Ultrasound

Elastography

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Not accepted

Interventions

Ultrasound application

Study Details

Brief summary:

The objective of this study is: (1) to investigate the correlation of ultrasound parameters (SW speed, Dispersion slope, Attenuation value, Normalized Local Variance, Liver / Kidney Intensity Ratio) with the pathological parameters (fibrosis, intralobular inflammation, ballooning degeneration and steatosis); (2) to evaluate the diagnostic performance of SW speed for liver fibrosis, Dispersion slope for intralobular inflammation and Attenuation value for steatosis by comparison with the tissue diagnosis by liver biopsy.

Conditions

Nonalcoholic Steatohepatitis

Ultrasound

Elastography

Study ID

NCT04012242

Start date

Jun 15, 2019

Status verified date

Feb, 2022

Completion date

Jul 31, 2022

Anticipated

Primary completion date

Jul 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Nonalcoholic fatty liver disease (NAFLD) patients who are scheduled for liver biopsy for the differential diagnosis of NASH and/or NAFLD patients who are scheduled for the MR elastography (MRE) and MRI-proton density fat friction (MRI-PDFF).
  • Without a history of alcohol use, which lead to alcoholic hepatic involvement (pure alcohol below 30 g/day for male, 20 g/day for female).

Exclusion Criteria:

  • Patients with endocrine disorder (hypopituitarism, growth hormone deficiency, hyperthyroidism etc.), serious nutrition disorder, and drug-induced hepatic involvement (steroid, tamoxifen, valproic acid, amiodarone etc.), which may lead to the steatosis
  • Hepatitis B, Hepatitis C and HIV patients
  • Primary biliary cholangitis, Primary sclerosing cholangitis, and Autoimmune hepatitis patients
  • Wilson's disease, α1-antitrypsin deficiency, and hemochromatosis patients
  • Malignant liver tumor, common bile duct stone, and jaundice patients
  • Patients after jejunoileal bypass surgery or massive intestinal resection surgery
  • Patients whose treatment changes during the period between imaging examination and liver biopsy, including medications such as antidiabetic drugs and other treatments which may change the fat deposition or inflammation of liver.

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

NAFLD patients who are scheduled for liver biopsy

Interventions

Ultrasound application

Shear wave elastography, shear wave dispersion, attenuation imaging, and intensity analysis

Primary outcome measure

  • Diagnostic performance of Dispersion slope for intralobular inflammation (A01 vs. A23) [ Time Frame: At the time of examination ]

Central Contacts and Locations

Central contacts

Fuminori Moriyasu, MD, PhD

+81-3-3402-3151moriyasy@iuhw.ac.jp

Katsutoshi Sugimoto, MD, PhD

+81-3-3342-6111sugimoto@tokyo-med.ac.jp

Locations

University of Southern California

Recruiting

Los Angeles, California, United States, 90007

Rocky Vista University

Recruiting

Parker, Colorado, United States, 80134

Northwestern University

Recruiting

Evanston, Illinois, United States, 60208

The Surgical Hospital at Southwoods

Recruiting

Boardman, Ohio, United States, 44512

University of Washington

Recruiting

Seattle, Washington, United States, 98195

More Information

Sponsor

Tokyo Medical University

Last update posted

Feb 8, 2022

Last verified

Feb, 2022

Keywords

  • Nonalcoholic Steatohepatitis
  • Ultrasound
  • Elastography
  • Dispersion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Tokyo Medical University on 2022-02-08.