跳至主要内容
临床试验/NCT04551716
NCT04551716已完成不适用

Assessment of Metabolic Associated Fatty Liver Disease (MAFLD) in Chinese Population Using ATI / SWE / SWD: a Prospective Multicenter Study

Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 448 人开始时间: 2020年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
448
试验地点
1
主要终点
Correlation between ATI / SWD / SWE parameters and the degree of steatosis, inflammation and fibrosis in MAFLD patients

研究概览

简要总结

Attenuation imaging (ATI) technology independently developed by Canon medical is a non-invasive examination technology for quantitative detection and analysis of liver steatosis. The technique is simple, rapid and quantitative diagnosis, and is suitable for screening and popularization of early liver steatosis in MAFLD. As noninvasive and effective detection measures of liver inflammation and liver fibrosis, SWD and SWE are more and more widely used in the quantitative diagnosis of liver inflammation and fibrosis. Therefore, ATI combined with SWD / SWE detection can quantitatively diagnose different pathological stages (steatosis, necrotizing inflammation and liver fibrosis) in the development of MAFLD, so as to provide an important basis for treatment.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • being a Chinese citizen aged 18 to 85 years;
  • meeting the diagnostic criteria for MAFLD;
  • willing and able to provide informed consent;
  • having a platelet count of at least 50 × 109/L and prothrombin activity of ≥50%.

排除标准

  • The pregnant.
  • Patients who have received or are undergoing systemic chemotherapy.
  • Patients with hepatitis C, alcoholic liver disease (more than 5 years of drinking history, equivalent to alcohol volume ≥ 40g / D in male and ≥ 20g / D in female), drug-induced liver disease or autoimmune hepatitis.
  • Those who re fuse to sign informed consent;
  • There was a significant risk of bleeding (platelet < 50x109 / L, prothrombin activity < 50%).

结局指标

主要结局

Correlation between ATI / SWD / SWE parameters and the degree of steatosis, inflammation and fibrosis in MAFLD patients

时间窗: from October 2020 to june 2022

次要结局

未报告次要终点

研究者

发起方
Chinese PLA General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ping Liang

Principal Investigator

Chinese PLA General Hospital

研究点 (1)

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