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临床试验/NCT07594834
NCT07594834尚未招募不适用

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.

Haibo Shao0 个研究点目标入组 20 人开始时间: 2026年6月30日最近更新:
适应症
干预措施

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

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

No Intervention

experimental group

Experimental

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时间窗: Immediately assess the extent of the ablation after the ablation needle is withdrawn.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

发起方
Haibo Shao
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Haibo Shao

offices director

First Hospital of China Medical University

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