NCT07389889尚未招募不适用
Percutaneous Robotic Navigation Microwave Ablation Versus CT-guided Microwave Ablation in the Treatment of Pulmonary Nodules With Ground-glass Opacity: A Prospective Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 116
- 主要终点
- Accuracy of puncture
研究概览
简要总结
- To compare the precision of robot-guided microwave ablation and CT-guided microwave ablation in the treatment of ground-glass nodules.
- To evaluate the safety of robot-assisted microwave ablation and CT-guided microwave ablation in the treatment of ground-glass nodules.
- Explore the application potential of robot navigation microwave ablation technology in the treatment of pulmonary nodules.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 85 years
- •Nodules measuring 3-30mm with ground-glass opacities constituting ≥75% of the lesion
- •Preoperative clinical evaluation confirming no hilar or mediastinal lymph node metastasis and no distant metastasis
- •Patients diagnosed as stage IA primary peripheral lung cancer according to the UICC 8th TNM staging system, and with one of the following conditions:
- •(i) cannot undergo surgical resection due to poor cardiopulmonary function or advanced age (ii) refusing or unwilling to undergo surgical resection (iii) with newly developed or residual pulmonary nodules after early-stage primary lung cancer surgery (iv) with unilateral lung disease who cannot undergo unilateral surgical resection (v)with multiple primary lung cancers unsuitable for surgical resection
- •Preoperative ECOG physical status score is 0/1
- •ASA score is I-III
- •Patients voluntarily participate in this study and sign the informed consent form
排除标准
- •Smoking cessation duration <2 weeks
- •Lesions adjacent to pulmonary artery-vein main trunks
- •Lesions near the hilum or adjacent to lobar bronchi
- •Pregnancy or lactation status
- •Severe mental disorders
- •History of other malignancies within 5 years
- •Unstable angina or myocardial infarction within 6 months with coronary angiography showing severe stenosis of major coronary branches
- •Cerebral infarction or hemorrhage within 6 months
- •Continuous systemic corticosteroid therapy within 1 month
- •Patients or their authorized persons who do not wish to comply with the study protocol
- •Patients with other investigator-assessed ineligibility for the trial
研究组 & 干预措施
Group A: Experimental group: Microwave ablation under robot navigation
Active Comparator
Microwave ablation under robot navigation
干预措施: Robot (Procedure)
Group B: CT-guided microwave ablation
Sham Comparator
干预措施: CT scan (Procedure)
结局指标
主要结局
Accuracy of puncture
时间窗: 24 month
The proportion of patients who are successfully punctured to the target pulmonary nodule on the first attempt of puncture among all patients; whether the puncture is successful is validated by CT scan.
次要结局
未报告次要终点
研究者
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