Innovative Liver Elasticity, Attenuation, and Dispersion Ultrasound Study

• Conditions: Nonalcoholic Steatohepatitis; Ultrasound; Elastography

• 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

Study Timeline

• Study Start: 2019-06-15
• Study First Submitted: 2019-06-27
• Study First Submitted QC: 2019-07-07
• Study First Posted: 2019-07-09
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-06
• Last Update Posted: 2022-02-08
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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 of Southern California; 🇺🇸 Los Angeles, California, United States

Rocky Vista University; 🇺🇸 Parker, Colorado, United States

Northwestern University; 🇺🇸 Evanston, Illinois, United States

The Surgical Hospital at Southwoods; 🇺🇸 Boardman, Ohio, United States

University of Washington; 🇺🇸 Seattle, Washington, United States

SunYatSen University First Hospital; 🇨🇳 Guangzhou, China

SunYatSen University Third Hospital; 🇨🇳 Guangzhou, China

Zhejiang University No. 2 Hospital; 🇨🇳 Hangzhou, China

University Paris Nord; 🇫🇷 Paris, France

University of Erlangen; 🇩🇪 Erlangen, Germany

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