Comparison of Hepatus and FibroScan for Evaluation of Fibrosis and Steatosis in Chronic Hepatitis B or NAFLD Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Consistency of liver stiffness and steatosis results in the same location between Hepatus in continuous measurement mode and FibroScan in single detection mode.
研究概览
简要总结
Totals of 400 chronic hepatitis B or non-alcoholic fatty liver disease (NAFLD) patients with or without cirrhosis will be enrolled. Patients' clinical characteristics, including alanine aminotransferase, aspartic aminotransferase, total bilirubin, direct bilirubin, indirect bilirubin, triglyceride and total cholesterol, hepatitis B surface antigen, steatosis, and liver stiffness measurement will be collected. The consistence of liver fibrosis and steatosis assessment between Hepatus and FibroScan will be evaluated in this study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with or without cirrhosis diagnose as chronic hepatitis B or non-alcoholic fatty liver disease;
- •Age above 18 years;
- •Signature of informed consent.
排除标准
- •Patients with HCV and/or other viral hepatitis, autoimmune liver disease, alcoholic liver disease, genetic liver disease or other chronic liver diseases;
- •Patients with decompensated cirrhosis;
- •Patients with serum total bilirubin level higher than 51 umol/L;
- •Patients with liver malignant lesion, hemangiomas, giant liver cysts and other liver lesions;
- •Patients with HIV infections;
- •Patients after liver transplantation or TIPS;
- •Pregnant women;
- •Patients with Budd-Chiari syndrome, chronic congestive heart failure, constrictive pericarditis or other liver congestion lesions.
结局指标
主要结局
Consistency of liver stiffness and steatosis results in the same location between Hepatus in continuous measurement mode and FibroScan in single detection mode.
时间窗: 1 to 3 years
Consistency of liver stiffness and steatosis between Hepatus and FibroScan.
次要结局
- Comparison of measurement performance in Hepatus under continuous detection mode and in FibroScan through single detection mode.(1 to 3 years)
- Consistency of liver stiffness and steatosis results between Hepatus in continuous measurement mode and FibroScan in single detection mode through the respective localization methods.(1 to 3 years)
- Consistency of liver stiffness and steatosis results between Hepatus and FibroScan in single detection mode.(1 to 3 years)
研究者
Hong You
Vice President of Beijing Friendship Hospital
Beijing Friendship Hospital