Innovative Liver Elasticity, Attenuation, and Dispersion Ultrasound Study

Study Overview
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Brief Summary
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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.

Official Title
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Innovative Liver Elasticity, Attenuation, and Dispersion Ultrasound Study for Patients With Nonalcoholic Steatohepatitis

Conditions
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Nonalcoholic Steatohepatitis, Ultrasound, Elastography

Intervention / Treatment
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* Diagnostic Test: Ultrasound application


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NAFLD patients who are scheduled for liver biopsy<br> | Diagnostic Test: Ultrasound application<br>* Shear wave elastography, shear wave dispersion, attenuation imaging, and intensity analysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of Dispersion slope for intralobular inflammation (A01 vs. A23) |  | At the time of examination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between ultrasound parameters and the pathological parameters |  | 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 Liver/Kidney Intensity Ratio for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3) |  | At the time of examination | 
| Diagnostic performance of the computer aided algorithm for NASH |  | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nonalcoholic Steatohepatitis, Ultrasound, Elastography, Dispersion