Prospective, Multicenter, Single-group Target Study to Evaluate the Safety and Efficacy of Microwave Ablation Therapy in Patients With Primary Liver Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 61
- 试验地点
- 26
- 主要终点
- Complete tumor ablation rate
研究概览
简要总结
Through the implementation of prospective, multi-center, single-group target value research to verify the safety and effectiveness of the microwave ablation treatment system for the ablation treatment of primary liver cancer.
详细描述
The safety and effectiveness of the microwave ablation treatment system produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd. for the ablation treatment of primary liver cancer is verified through the implementation of prospective, multi-center, single-group target value research. According to the requirements of the trial, 139 patients who were diagnosed with primary liver cancer before surgery and met the inclusion criteria without any exclusion criteria were selected for treatment of their liver cancer with a microwave ablation treatment system, 1 month, 3 months and 6 months after surgery Carry out clinical and imaging follow-up to evaluate the safety of the operation and the effect of tumor ablation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathological and/or clinical diagnosis confirmed as primary liver cancer (hepatocellular carcinoma).
- •Single tumor with maximum diameter ≤ 5cm ; or tumors number ≤ 3 with maximum diameter ≤ 3cm.
- •No invasion of blood vessels, gallbladder, adjacent organs and distant metastasis.
- •Child-Pugh class A or B classification, or meet the standard after treatment.
- •Able to understand the content of clinical trials, voluntarily participate in the trial and sign informed consent.
排除标准
- •Pregnant or breastfeeding, or preparing to become pregnant during the trial.
- •Participating in clinical trials of other devices or drugs.
- •Uncorrectable coagulation dysfunction (after corrective treatment, the PT exceeds the normal control value by more than 3s).
- •PLT <50x109/L.
- •Intractable massive ascites.
- •Cachexia.
- •MRI examination is contraindicated or the investigator judges it is not suitable for MRI examination.
- •Patients with bleeding from esophageal (fundus of stomach) varicose veins 1 month before surgery.
- •Patients with impaired consciousness or unable to cooperate with treatment.
- •The investigator judged that it is not suitable to participate in clinical trials.
结局指标
主要结局
Complete tumor ablation rate
时间窗: 1 month after surgery
the percentage of complete ablation subjects for all subjects undergoing ablation surgery. Complete ablation: Follow up by MRI scan 1 month after surgery, the area where the tumor is located is in the low-density arterial phase without enhancement; if the tumor is followed up by MRI scan 1 month after surgery, there is enhancement in the local arterial phase within the tumor lesion, which suggests that the tumor remains. The tumor could be treated by re-ablation; if there is still residual tumor in MRI scan 1 month after the second ablation, it is judged as incomplete ablation.
次要结局
- First complete tumor ablation rate(1 month after surgery)
- Complete ablation rate of lesions(1 month after surgery)