A Prospective Multicenter Cohort Control Study of Percutaneous Microwave Ablation and Laparoscopic Resection for Hepatocellular Carcinoma With a Diameter of 3.1 ~ 5.0cm
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,134
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
The study was a prospective multicenter cohort control study, which was divided into 1:1 groups to compare the clinical efficacy of percutaneous microwave ablation and laparoscopic hepatocellular carcinoma resection (tumor diameter 3.1-5.0cm).
详细描述
Research objectives:
To compare the clinical efficacy of percutaneous microwave ablation and laparoscopic resection for hepatocellular carcinoma (tumor diameter 3.1-5.0cm).
Research background:
Liver cancer is the sixth most common tumor in the world and the second leading cause of death. Due to the hepatitis B epidemic, the incidence of liver cancer in China is very high, accounting for about half of the global statistics on the number of new liver cancer cases and deaths each year. Current treatment guidelines recommend surgical resection or transplantation as the gold standard for the treatment of very early or early HCC patients. Meanwhile, local ablation is gradually accepted by clinicians for its minimally invasive nature, safety and efficacy, and it is recommended as an alternative treatment for tumors within 3cm. However, the choice of treatment for 3.1-5cm HCC based on a number of current retrospective studies is controversial. Therefore, we designed this study to provide reliable prospective data to support the selection of therapeutic modalities for HCC.
Technical introduction:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •1.Older than 18 years old, regardless of gender; 2.In patients without cirrhosis background, hepatocellular carcinoma was definitely pathologically diagnosed within 1 month before surgery. In patients with cirrhosis background, dynamic contrast enhanced MRI/ multi-stage dynamic enhanced CT were used to determine the characteristic vascular signs of primary liver cancer (rapid heterogeneous vascular enhancement in arterial phase, rapid elution in venous phase or delayed phase); 3.The number of tumors was ≤3, and the maximum diameter of at least one tumor was 3.1-5.0cm; 4.No vascular and lymph node invasion and distant metastasis; 5.Liver function: child-pugh A or B (assessed within 14 days before surgery); 6.Subjects will understand the purpose of the study, voluntarily participate and sign the informed consent.
排除标准
- •1.Severe hepatic decompensation, presence of hepatic encephalopathy, massive ascites or gastrointestinal bleeding within 1 month; 2.Clotting disorders or bleeding tendencies (platelet count <50 x 109 / L or INR>1.5); 3.Patients with severe cardiac, pulmonary and renal insufficiency; 4.Combined with active infection; 5.Pregnant patients; 6.A history of drug abuse and mental illness; 7.Inability to tolerate pneumoperitoneum; 8.Other studies or anti-tumor therapists in the first four weeks of the study; 9.The researchers determined that there were any other factors that were inappropriate for inclusion or that affected participants' participation in the study.
结局指标
主要结局
Overall survival
时间窗: 60 months
Defined as the length of time from the beginning of treatment to death or the last follow-up (if no death).
次要结局
- Rate of extrahepatic metastasis(60 months)
- Local rate of progression(60 months)
- Progression-free survival(60 months)
- Intrahepatic recurrence rate(60 months)
研究者
Ping Liang
Interventional ultrasound department
Chinese PLA General Hospital