此页面是自动翻译的，不保证翻译的准确性。请参阅英文版对于源文本。

CT-Free Electromagnetic Navigation Percutaneous Localization for Pulmonary Nodules Undergoing Sublobar Resection

2026年7月29日更新者：Jianle Chen

Clinical Evaluation of CT-Free Electromagnetic Navigation Percutaneous Localization System for Pulmonary Nodules Undergoing Sublobar Resection: A Multicenter Observational Cohort Study

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.

研究概览

地位

完全的

条件

研究类型

观察性的

注册 (实际的)

153

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

中国
- Jiangsu
  - Nantong、Jiangsu、中国
    - Nantong First People's Hospital
  - Nantong、Jiangsu、中国
    - Nantong Sixth People's Hospital
  - Nantong、Jiangsu、中国
    - Nantong University Affiliated Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

成人
年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Patients with pulmonary nodules requiring preoperative localization before sublobar lung resection at multiple participating centers.

描述

Inclusion Criteria:

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.

Exclusion Criteria:

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
CT-Free Electromagnetic Navigation Localization Patients receiving CT-Free electromagnetic navigation percutaneous localization before sublobar resection for pulmonary nodules.
CT-Guided Localization Patients receiving conventional CT-guided localization before sublobar resection for pulmonary nodules.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Proportion of Participants With Successful Localization Based on Marker-to-Nodule Distance ≤10 mm 大体时间：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.	Immediately after surgical resection

次要结果测量

结果测量	措施说明	大体时间
Proportion of Participants Requiring Additional Localization Procedures 大体时间：During surgery	The proportion of participants requiring additional localization methods because of unsuccessful or inaccurate initial localization.	During surgery
Number of Participants With Procedure-Related Complications 大体时间：Within 30 days after surgery	Procedure-related complications including pneumothorax, pulmonary hemorrhage, and infection occurring after localization and surgery.	Within 30 days after surgery
Duration of Pulmonary Nodule Localization Procedure 大体时间：From initiation to completion of the localization procedure	The duration from initiation of localization preparation to completion of marker placement.	From initiation to completion of the localization procedure
Mean Distance Between Localization Marker and Pulmonary Nodule Center (mm) 大体时间：Immediately after surgical specimen resection	The mean distance between the localization marker and the pulmonary nodule center measured immediately after surgical specimen resection.	Immediately after surgical specimen resection
Mean Duration of Postoperative Hospital Stay 大体时间：Up to 30 days after surgical resection	The mean duration of hospitalization after surgical resection, calculated from the date of surgery to the date of hospital discharge.	Up to 30 days after surgical resection

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Jianle Chen

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年6月24日

初级完成 (实际的)

2026年3月28日

研究完成 (实际的)

2026年3月28日

研究注册日期

首次提交

2026年7月19日

首先提交符合 QC 标准的

2026年7月29日

首次发布 (实际的)

2026年8月4日

研究记录更新

最后更新发布 (实际的)