Clinical Evaluation of CT-Free Electromagnetic Navigation Percutaneous Localization System for Pulmonary Nodules Undergoing Sublobar Resection: A Multicenter Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 153
- 试验地点
- 3
- 主要终点
- Proportion of Participants With Successful Localization Based on Marker-to-Nodule Distance ≤10 mm
研究概览
简要总结
Pulmonary nodules, particularly small and non-palpable nodules, present challenges for accurate localization during sublobar lung resection. This multicenter observational cohort study evaluated the feasibility, accuracy, and safety of CT-Free electromagnetic navigation percutaneous localization for pulmonary nodules requiring sublobar resection.
Patients who underwent CT-Free electromagnetic navigation localization were compared with patients who received conventional CT-guided localization. The primary outcome was localization success rate, defined as the distance between the localization marker and the pulmonary nodule center being within 10 mm.
Secondary outcomes included localization procedure time, conversion rate to other localization methods, surgical success rate, perioperative complications, postoperative hospitalization duration, and medical resource utilization.
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
- •Adults aged 18 years or older.
- •Patients with pulmonary nodules requiring sublobar resection.
- •Non-palpable pulmonary nodules requiring preoperative localization.
- •Patients undergoing CT-Free electromagnetic navigation localization or CT-guided localization.
排除标准
- •Central pulmonary nodules unsuitable for localization.
- •Patients unable to undergo sublobar resection.
- •Patients with severe cardiopulmonary dysfunction or major organ dysfunction.
- •Pregnancy or breastfeeding.
- •Patients participating in other clinical trials.
结局指标
主要结局
Proportion of Participants With Successful Localization Based on Marker-to-Nodule Distance ≤10 mm
时间窗: Immediately after surgical resection
The proportion of participants with successful pulmonary nodule localization, defined as a distance between the localization marker and the pulmonary nodule center of ≤10 mm, measured by postoperative pathological specimen evaluation.
次要结局
- Number of Participants With Procedure-Related Complications(Within 30 days after surgery)
- Duration of Pulmonary Nodule Localization Procedure(From initiation to completion of the localization procedure)
- Mean Distance Between Localization Marker and Pulmonary Nodule Center (mm)(Immediately after surgical specimen resection)
- Proportion of Participants Requiring Additional Localization Procedures(During surgery)
- Mean Duration of Postoperative Hospital Stay(Up to 30 days after surgical resection)
研究者
Jianle Chen
Professor and Chief Physician
Affiliated Hospital of Nantong University