NASH
Conditions
Interventions
None listed
Sponsors
Tokyo Medical University
Hyogo Medical College Kurume University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female aged 20 or older. 2. Scheduled cases for liver biopsy for the (differential) diagnosis of NASH. (for the institutes where biopsy is not available, the scheduled cases for the MRE and MRI-PDFF examination) 3. Without a history of alcohol use, which lead to alcoholic hepatic involvement. (pure alcohol below 30g/day for male, 20g/day for female)
Exclusion criteria
Exclusion criteria: 1. 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. 2. Hepatitis B, Hepatitis C and HIV patients (Even NAFLD complicated with such clinical condition should be excluded) 3. Primary biliary cholangitis, Primary sclerosing cholangitis, and Autoimmune hepatitis patients 4. Wilson's disease, a1-antitrypsin deficiency, and Hemochromatosis patients. 5. Malignant liver tumor, common bile duct stone, and jaundice patients 6. Patients after jejunoileal bypass surgery or massive intestinal resection surgery. 7. Patients whose treatment changes during the period betweenimage examination and liver biopsy, including medications such as antidiabetic drugs and other treatments which may change the fat deposition or inflammation of liver. However,patients that have taken medicications before this period may be considered for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the diagnostic performance of Dispersion slope for intralobular inflammation (A01 vs. A23). | — |
Secondary
| Measure | Time frame |
|---|---|
| (a) The correlation between ultrasound parameters (SW speed, Dispersion slope, Attenuation value, Normalized Local Variance, and Liver/Kidney Intensity Ratio) and the pathological parameters (liver fibrosis, intralobular inflammation, ballooning and steatosis). (b) Diagnostic performance of SW speed for fibrosis (F0 vs. F1234, F01 vs. F234, F012 vs. F34, and F0123 vs. F4). (c) Diagnostic performance of Normalized Local Variance for fibrosis (F0 vs. F1234, F01 vs. F234, F012 vs. F34, and F0123 vs. F4). (d) Diagnostic performance of Normalized Local Variance for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3). (e) Diagnostic performance of Dispersion slope for intralobular inflammation (A0 vs. A123, and A012 vs. A3). (f) Diagnostic performance of Attenuation value for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3). (g) Diagnostic performance of Liver/Kidney Intensity Ratio for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3). (h) Diagnostic performance of the computer aided algorithm for NASH (i) Diagnostic performance of MRI-PDFF for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3). (j) Diagnostic performance of CAP for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3). (k) Diagnostic performance of MRE for fibrosis (F0 vs. F1234, F01 vs. F234, F012 vs. F34, and F0123 vs. F4). | — |
Countries
Japan,North America,Europe
Contacts
Public ContactKatsutoshi Sugimoto
Tokyo Medical University Dept. of Gastroenterology and Hepatology
Outcome results
None listed