Comparison of Robot-Assisted Versus Manual Puncture for Ablation of Pulmonary Nodules: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Number of Needle Adjustments
研究概览
简要总结
Pulmonary nodule ablation is an established minimally invasive treatment for selected patients with pulmonary nodules. Accurate puncture is critical for procedural efficiency and safety. This prospective observational cohort study aims to compare robot-assisted and conventional manual CT-guided puncture techniques for pulmonary nodule ablation. The primary outcomes are the number of intraoperative CT scans and needle adjustments. Secondary outcomes include puncture success, puncture accuracy, radiation exposure, and procedure-related complications. The results will provide evidence regarding the clinical effectiveness and safety of robot-assisted puncture in pulmonary nodule ablation.
详细描述
Pulmonary nodule ablation has become an important minimally invasive treatment option for patients who are unsuitable for surgical resection or who prefer image-guided local therapy. Successful CT-guided ablation depends on accurate needle placement, which may require repeated CT scans and multiple needle adjustments when conventional manual puncture is used. Robotic navigation systems have the potential to improve puncture precision and procedural efficiency while maintaining procedural safety.
This prospective observational cohort study compares robot-assisted puncture using the TH-S1 robotic navigation system with conventional manual CT-guided puncture in patients undergoing pulmonary nodule ablation. Participants are assigned to treatment groups according to routine clinical practice without randomization.
The primary outcomes are the number of intraoperative CT scans and needle adjustments. Secondary outcomes include puncture success, puncture deviation distance, radiation exposure measured by dose-length product (DLP), and procedure-related complications. Baseline characteristics will be adjusted using propensity score-based weighting methods before comparative analyses.
The study aims to evaluate whether robot-assisted puncture improves procedural efficiency while maintaining comparable safety and technical success relative to conventional manual puncture.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Patients with peripheral pulmonary nodules scheduled for CT-guided thermal ablation.
- •Eligible for either robot-assisted or conventional manual puncture according to routine clinical practice.
- •Written informed consent provided.
排除标准
- •Pulmonary nodules unsuitable for percutaneous ablation because of proximity to major vessels, bronchi, or other critical structures.
- •Previous thoracic surgery or local treatment affecting puncture planning.
- •Severe cardiopulmonary dysfunction or other contraindications to CT-guided ablation.
- •Pregnancy.
- •Inability or unwillingness to provide informed consent.
结局指标
主要结局
Number of Needle Adjustments
时间窗: During the procedure
Total number of needle adjustments required to achieve the planned puncture trajectory.
Number of Intraoperative CT Scans
时间窗: During the procedure
Total number of CT scans performed during the puncture procedure.
次要结局
- Technical Success Rate(During the procedure)
- Puncture Deviation(During the procedure)
- Radiation Exposure(During the procedure)
- Procedure-Related Complications(Within 48 hours after the procedure)
研究者
Jianxing He
Professor of Thoracic Surgery
The First Affiliated Hospital of Guangzhou Medical University