A Clinical Study to Evaluate the Efficacy and Safety of A Optimized Computed Tomography-guided Pulmonary Nodule Microcoil Localization Technique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- The proportion of patients with pneumothorax.
研究概览
简要总结
In the early stage of the study, the CT-guided micro-coil locating method for pulmonary small nodules was optimized. This study will use a single set of target values non-randomized controlled trials to evaluate the safety and effectiveness of the optimized pre-loaded micro-coil locating method in pulmonary small nodules.
详细描述
A series of optimization and improvement measures were tried for the complications of the CT-guided micro-coil locating method. After discussion, the method of micro-coil pre-loaded in the puncture needle and sealed first, and then for subsequent locating has more advantageous. The method avoids the direct penetration of the puncture needle into the atmosphere during operation, and the operation is simpler. In vitro tests of isolated lung specimens and pre-tests of 9 clinical patients were carried out. The results showed that this method not only reduced the number of operators on site, but also had the tendency to shorten the operation time, reduce the incidence of pneumothorax, and improve the success rate. However, there is currently no rigorous scientific research to provide objective evidence for its safety and effectiveness.
Therefore, this study intends to use a single set of target values non-randomized controlled trials to evaluate the safety and effectiveness of the optimized pre-loaded micro-coil locating method in pulmonary small nodules.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18 years old (including 18 years old) and 85 years old (including 85 years old);
- •The nodule is clinically suspected to be malignant;
- •Those who have no distant metastases;
- •Intrapulmonary lesions must meet the following imaging criteria: ① pure ground glass opacity or non-pure ground glass opacity of solid components ≦ 25%; ②solid nodules with diameter ≦ 1 cm or solid components≦ 1 cm non- purely ground glass, and the distance between the solid component of the nodule and the visceral pleural ≧0.5cm; ③ no pleural traction or involving the pleura.
排除标准
- •The lesion site is not suitable for percutaneous lung puncture;
- •those who have pneumothorax and pleural effusion;
- •Poor general condition, severe damage to cardiopulmonary function, cachexia, and inability to tolerate surgery;
- •Those who refuse surgery;
- •Those who did not sign the informed consent form.
结局指标
主要结局
The proportion of patients with pneumothorax.
时间窗: half an hour after positioning
Pneumothorax definition: The chest radiograph is examined in the lateral position half an hour after positioning. If a clear pneumothorax line is seen on the chest radiograph, that is, the boundary line between the atrophic lung tissue and the pleural cavity, the pneumothorax is considered to occur.
次要结局
- Positioning success rate(thoracoscopic surgery)
- Proportion of patients with complications other than pneumothorax(thoracoscopic surgery)
- Operation time(At the end of the positioning operation)
- Number of operators(At the end of the positioning operation)