Status:
UNKNOWN
Innovative Liver Elasticity, Attenuation, and Dispersion Ultrasound Study
Lead Sponsor:
Tokyo Medical University
Conditions:
Nonalcoholic Steatohepatitis
Ultrasound
Eligibility:
All Genders
20+ years
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) w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 15 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2022
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04012242
Start Date
June 15 2019
End Date
July 31 2022
Last Update
February 8 2022
Active Locations (18)
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1
University of Southern California
Los Angeles, California, United States, 90007
2
Rocky Vista University
Parker, Colorado, United States, 80134
3
Northwestern University
Evanston, Illinois, United States, 60208
4
The Surgical Hospital at Southwoods
Boardman, Ohio, United States, 44512