This Study Aims to Provide New Evidence for Optimizing the Lung Cryoablation Strategy by Targeting High-risk Individuals With Incomplete Ice Ball Morphology in Lung Cryoablation. This is Achieved Through the Use of Selective Pulmonary Artery Embolization.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- ablation zone
研究概览
简要总结
This study targeted high-risk individuals with incomplete ablation and performed selective pulmonary artery embolization before lung cryoablation, which could enhance the therapeutic effect and reduce the risk of intraoperative bleeding. Previous studies have shown that selective pulmonary artery embolization before ablation has no adverse reactions related to embolization. In this study, gelatin sponge particles were used for selective pulmonary artery embolization. Gelatin sponge is an absorbable embolic material that can be absorbed and degraded in the human body within about 7 days, which has high safety and a low probability of adverse reactions. The surgical risks are detailed in the surgical protocol. The study aims to optimize the lung cryoablation strategy for high-risk individuals with incomplete ablation, aiming to improve the prognosis of high-risk recurrent patients. The two groups of patients underwent lung CT reexamination every three months after surgery to observe the tumor ablation situation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Individuals at high risk of incomplete ablation (for example, there are vessels with a diameter greater than 3mm within 1cm around the pulmonary nodule);
- •Scheduled for lung cryoablation, meeting the surgical indications and without any specific contraindications;
- •The long diameter of the lung tumor is less than 3cm;
- •The single cryoablation needle will be used. -
排除标准
- •Postoperative complications such as massive pneumothorax and bleeding occurred, which affected the observation of the ice ball's shape;
- •Poor image quality or incomplete images. -
研究组 & 干预措施
control group
experimental group
干预措施: Pulmonary artery embolization (Procedure)
结局指标
主要结局
ablation zone
时间窗: Immediately assess the extent of the ablation after the ablation needle is withdrawn.
The CT images obtained during the operation are subjected to three-dimensional reconstruction, and the ROI is delineated. The long diameter, short diameter and volume of the ablation area are measured.Compare the values of various aspects of the smiling areas between the experimental group and the control group.
次要结局
未报告次要终点
研究者
Haibo Shao
offices director
First Hospital of China Medical University
