NCT04012242Unknown不适用
Innovative Liver Elasticity, Attenuation, and Dispersion Ultrasound Study for Patients With Nonalcoholic Steatohepatitis
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 18
- 主要终点
- Diagnostic performance of Dispersion slope for intralobular inflammation (A01 vs. A23)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Diagnostic performance of Dispersion slope for intralobular inflammation (A01 vs. A23)
时间窗: At the time of examination
次要结局
- 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)
研究者
Katsutoshi Sugimoto
Associate Professor
Tokyo Medical University
研究点 (18)
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