Combi-elastography Assessment of HCC Recurrence After Thermal Ablation Multi-center Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- A index
研究概览
简要总结
Combined F index, A index,ATT index and spleen stiffness to predict tumor recurrence in different liver settings after thermal ablation of HCC.
详细描述
Thermal ablation is one of the established method for HCC treatment. Postoperative recurrence of HCC is one of the major factors leading to poor prognosis of HCC patients. Most studies have shown that the risk factors of recurrence include tumor size, tumor number and intrahepatic spread, etc.
Besides, the carcinogenic effects of inflammatory activity and fibrosis in liver background caused by chronic hepatitis also be related to the recurrence. In the study, combi-elastography imaging technology , not only the F index which is related to liver fibrosis stage can be obtained, but also the A index which is related to inflammation activity can be measured, this may provide a more valuable method for tumor recurrence of early prediction.
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
- •Aged 18 to 80 years of age, and gender not limited;Chronic hepatitis B patients;The lesions of liver have the histopathological diagnosis of HCC and within MiLan criteria;All lesions were performed thermal ablation surgery;Sign the informed consent.
排除标准
- •Lesions that unrealized complete inactivation evaluation by the enhanced imaging;Merging other systems' serious illness that can't cooperate with elastic imaging checking(such as heart failure, renal failure, such as mental illness);After liver transplantation patients;Patients with pregnancy.
结局指标
主要结局
A index
时间窗: baseline
A index is linked to the degree of hepatitis,and it can be available by ultrasound elastography checking.
F index
时间窗: baseline
F index is linked to the degree of liver fibrosis,and it can be available by ultrasound elastography checking.
ATT index
时间窗: baseline
ATT index is linked to the degree of steatosis of liver,and it can be available by ultrasound elastography checking.
Spleen stiffness
时间窗: baseline
Spleen stiffness can be available by ultrasound elastography checking.
次要结局
未报告次要终点
研究者
Ping Liang
Chief physician
Chinese PLA General Hospital