Efficacy and Safety of Radiofrequency Ablation of Malignant Pulmonary Nodules
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- complication rate
研究概览
简要总结
The objective of this study is to evaluate the outcomes of radiofrequency ablation in the treatment of patients with malignant pulmonary nodules（not exceed 3cm ）who are not suitable candidates for or refuse surgical resection.
详细描述
Percutaneous radiofrequency ablation (RFA) is a minimally invasive technique widely used to treat solid tumors. Patients with malignant pulmonary nodules will undergo a series of CT- guided percutaneous RFA procedures. During the procedures，percutaneous needles will be inserted into the target tissues under CT guidance，the needles deliver thermal energy and then destroy the tumors by causing coagulation necrosis via tissue heating. The purpose of this study is to assess the effectiveness and safety of RFA in pulmonary nodules （maximum tumor diameter ≦30 mm） was 10 mm apart from the big trachea, primary bronchi, esophagus, great vessels，heart and pleura. Preoperative and postoperative evaluations，including recent laboratory tests evaluated and imaging studies reviewed，will be performed both before and after the procedures.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed malignant pulmonary nodules.
- •Patients refuse or are not suitable for surgical resections.
- •1-3 pulmonary nodules , with a maximum tumor diameter ≦30 mm.
- •Minimum distance of nodules are at least 10 mm apart from the surrounding tissues as big trachea, primary bronchi, esophagus, great vessels，heart and pleura.
排除标准
- •Patients who has uncorrectable coagulation disorders, severe heart or pulmonary failure, or uncontrolled infections.
- •With extensive extrapulmonary or intrapulmonary metastasis.
- •Have taken anticoagulant as aspirin in one week.
- •Target nodules nearby pleura or other important hilum and mediastinum structures.
- •With metal implants are adjacent to the target tissues which will be covered with ablation area.
结局指标
主要结局
complication rate
时间窗: During the procedure or up to 5 years after the procedures
Including puncture-related complications such as pulmonary haemorrhage, hemothorax, pneumothorax, cardiac tamponade, and air embolism and ablation-related complications such as chest pain, pleural reactions, cough, and skin burns.
1- , 3- and 5-year survival rates
时间窗: up to 5 years after the procedures
次要结局
- changes of the size about the tumor on CT/MRI images(After the procedures up to three months)
研究者
Yueyong Xiao
Director of the Department
Chinese PLA General Hospital