Value of Liver Stiffness Measurement (LSM) in Predicting the Progress of Liver Fibrosis After Transcatheter Arterial Chemoembolization (TACE) for Hepatocellular Carcinoma, an Observational Study
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 主要终点
- The change of LSM(kpa) measured by FibroScan(a kind of external harmless ultrasonoscope)
研究概览
简要总结
Objective: To evaluate the efficacy of preoperative liver stiffness measurement(LSM) by FibroScan in predicting the progress of liver fibrosis and prognosis after transcatheter arterial chemoembolization (TACE) in hepatocellular carcinoma (HCC).
Background: Progress of liver fibrosis and liver failure and related poor prognosis after TACE which are not completely predictable by current method including Child-Pugh Classification. LSM is used to calculate the degree of liver fibrosis and is affected by several liver injury, e.g. elevated Alanine aminotransferase（ALT）, Aspartate transaminase(AST) and Bilirubin et al. The investigators assume that LSM could be use to predict progress of liver fibrosis and adverse effects after TACE in HCC.
Methods: At least 200 patients will be recruited in this prospective observational study with preoperative LSM, demographic, laboratory, radiological and other treatment-related factors. Participants will be followed up till death or to the end of study no matter the liver failure occurs or not. Data will be analyzed to build a mathematical predicting model.
Research hypothesis：TACE is related to progress of liver fibrosis and a mathematical model with LSM is able to predict the risk of liver failure and prognosis in HCC.
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
- 否
入选标准
- •age：18-80
- •HCC diagnosed by pathologist or physician according to Guidelines
- •Chronic Hepatitis B (CHB) background
- •receive at least 1 TACE
- •volunteer to join the research
排除标准
- •massive lesion with insufficient liver left for LSM examination
- •associated with other liver diseases: Chronic Hepatitis C(CHC),Autoimmune Hepatitis(AIH),Wilson's disease.
- •severe obesity(BMI>28)
- •pregnancy
- •other inappropriate situation defined by investigators.
结局指标
主要结局
The change of LSM(kpa) measured by FibroScan(a kind of external harmless ultrasonoscope)
时间窗: within 1 week pre-TACE and 1 week post-TACE
The investigators will investigate the value of LSM( kpa) by machine of FibroScan ( produced by France Echo). The investigators will record LSMs before and after each procedure of TACE. The investigators will calculate the change of LSMs of each participants.
次要结局
未报告次要终点