Quantification of Hepatic Steatosis in Patients With Fatty Liver Disease Using Attenuation Imaging With Different Ultrasound Frequency
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Attenuation coefficient (3MHz vs. 4MHz) in attenuating imaging
研究概览
简要总结
The objective of this study is: (1) to compare the feasibility (technical successes rate and reliability) in measuring attenuation coefficient between two different frequencies (3MHz, 4MHz) of ultrasound beam; (2) to evaluate and compare the diagnostic performance of attenuation coefficient for steatosis using two different frequencies (3MHz, 4MHz) of ultrasound beam by comparison with the pathologic results acquired by liver biopsy or surgery.
详细描述
Investigators measure the distance between the skin and liver capsule on B-mod images.
Investigators place a region of interest (ROI) avoiding reverberation artifacts and acquire attenuation coefficient for five times.
For participants who require a liver biopsy, investigators try to target the same area in the liver, where ROI was placed.
Investigators evaluate hepatic steatosis, lobular inflammation, and fibrosis of tissue of the liver using a scoring system suggested by Nonalcoholic Steatohepatitis Clinical Research Network.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants who are candidates for liver donation and scheduled liver biopsies for assessment of hepatic steatosis
- •Participants suspected of nonalcoholic fatty liver disease and scheduled for liver biopsy or surgery
排除标准
- •Participants with a BMI of less than 23
- •Participants underwent liver transplantation or right hepatectomy
- •Participants who have a large mass in the right liver
- •Participants who have a bleeding tendency (platelet count < 80000, prothrombin time and international normalized ratio > 1.5)
结局指标
主要结局
Attenuation coefficient (3MHz vs. 4MHz) in attenuating imaging
时间窗: During procedure
dB/cm/MHz
Percentage of fat within hepatocyte in pathological specimen
时间窗: During procedure
S0 (\<5%), S1(5%\~33%), S2(34%\~66%), and S3 (\>66%)
次要结局
未报告次要终点
研究者
Jong Keon Jang
Assistant Professor
Asan Medical Center