Innovative Liver Elasticity, Attenuation, and Dispersion Ultrasound Study
- Conditions
- Nonalcoholic SteatohepatitisUltrasoundElastography
- Interventions
- Diagnostic Test: Ultrasound application
- Registration Number
- NCT04012242
- Lead Sponsor
- Tokyo Medical University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 400
- 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).
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description NAFLD patients who are scheduled for liver biopsy Ultrasound application -
- Primary Outcome Measures
Name Time Method Diagnostic performance of Dispersion slope for intralobular inflammation (A01 vs. A23) At the time of examination
- Secondary Outcome Measures
Name Time Method Correlation between ultrasound parameters and the pathological parameters At the time of examination Diagnostic performance of the computer aided algorithm for NASH At the time of examination Diagnostic performance of SW speed for fibrosis (F0 vs. F1234, F01 vs. F234, F012 vs. F34, and F0123 vs. F4). At the time of examination Diagnostic performance of Normalized Local Variance for fibrosis (F0 vs. F1234, F01 vs. F234, F012 vs. F34, and F0123 vs. F4) At the time of examination Diagnostic performance of Normalized Local Variance for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3) At the time of examination Diagnostic performance of Dispersion slope for intralobular inflammation (A0 vs. A123, and A012 vs. A3) At the time of examination Diagnostic performance of Attenuation value for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3) At the time of examination Diagnostic performance of CAP for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3). At the time of examination Diagnostic performance of MRE for fibrosis (F0 vs. F1234, F01 vs. F234, F012 vs. F34, and F0123 vs. F4). At the time of examination Diagnostic performance of Liver/Kidney Intensity Ratio for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3) At the time of examination Diagnostic performance of MRI-PDFF for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3). At the time of examination
Trial Locations
- Locations (18)
University Paris Nord
🇫🇷Paris, France
Policlinico Umberto I, Univ. La Sapienza
🇮🇹Rome, Italy
Rocky Vista University
🇺🇸Parker, Colorado, United States
University of Erlangen
🇩🇪Erlangen, Germany
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
Kurume University
🇯🇵Kurume, Japan
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Charing Cross Hospital / Imperial College London
🇬🇧London, United Kingdom
The Surgical Hospital at Southwoods
🇺🇸Boardman, Ohio, United States
University of Pavia
🇮🇹Pavia, Italy
University of Leipzig
🇩🇪Leipzig, Germany
Hyogo Medical University
🇯🇵Hyogo, Japan
SunYatSen University First Hospital
🇨🇳Guangzhou, China
SunYatSen University Third Hospital
🇨🇳Guangzhou, China
Zhejiang University No. 2 Hospital
🇨🇳Hangzhou, China
University of Southern California
🇺🇸Los Angeles, California, United States
Northwestern University
🇺🇸Evanston, Illinois, United States
University of Washington
🇺🇸Seattle, Washington, United States