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NAVIGATE 24-Month Results: Electromagnetic navigation bronchoscopy for pulmonary lesions at 37 centers in Europe and the United States
（Journal of Thoracic Oncology, IF: 15.609）
- Erik E. Folch, Mark R. Bowling, Michael A. Pritchett, Septimiu D. Murgu, Michael A. Nead, Javier Flandes, William S. Krimsky, Amit K. Mahajan, Gregory P. LeMense, Boris A. Murillo, Sandeep Bansal, Kelvin Lau, Thomas R. Gildea, Merete Christensen, Douglas A. Arenberg, Jaspal Singh, Krish Bhadra, D. KyleHogarth, Christopher W. Towe, Bernd Lamprecht, Michela Bezzi, Jennifer S. Mattingley, Kristin L. Hood, Haiying Lin, Jennifer J. Wolvers, Sandeep J. Khandhar, for the NAVIGATE Study Investigators
- CORRESPONDENCE TO: efolch@mgh.harvard.edu
Introduction 导言Electromagnetic navigation bronchoscopy (ENB) is a minimally invasive, image-guided approach to access lung lesions for biopsy or localization for treatment. However, no studies have reported prospective 24-month follow-up from a large, multinational, generalizable cohort. This study evaluated ENB safety, diagnostic yield, and usage patterns in an unrestricted, real-world observational design.
电磁导航支气管镜（ENB）是一种微创、图像引导的方法，用于获取肺部病变活检或治疗定位。然而，没有研究报告对一个大型、跨国、普遍性队列进行了24个月的前瞻性随访。本研究采用无限制的真实观察设计，评估了ENB的安全性、诊断率和使用模式。
Methods 方法
The NAVIGATE single-arm, pragmatic cohort study (NCT02410837) enrolled subjects at 37 academic and community sites in 7 countries with prospective 24-month follow-up. Subjects underwent ENB using the super Dimension navigation system versions 6.3 to 7.1. The prespecified primary endpoint was procedure-related pneumothorax requiring intervention or hospitalization.
NAVIGATE单臂实用性队列研究（NCT02410837）在7个国家的37个学术和社区站点招募受试者，并进行24个月的前瞻性随访。受试者使用超级Dimension导航系统版本6.3至7.1进行ENB。预先确定的主要试验终点是需要干预或住院治疗的手术相关气胸。
Results 结果A total of 1,388 subjects were enrolled for lung lesion biopsy (1,329; 95.7%), fiducial marker placement (272; 19.6%), dye marking (23; 1.7%), and/or lymph node biopsy (36; 2.6%). Concurrent endobronchial ultrasound-guided staging occurred in 456 subjects. General anesthesia (78.2% overall, 56.6% Europe, 81.4% US), radial endobronchial ultrasound (50.6%, 4.0%, 57.4%), fluoroscopy (85.0%, 41.7%, 91.0%), and rapid on-site evaluation use (61.7%, 17.3%, 68.5%) differed between regions. Pneumothorax and bronchopulmonary hemorrhage occurred in 4.7% and 2.7% of subjects, respectively (3.2% [primary end point] and 1.7% requiring intervention or hospitalization). Respiratory failure occurred in 0.6%. The diagnostic yield was 67.8% (range 61.9%- 70.7%; 55.2% Europe, 69.8% US). Sensitivity for malignancy was 62.6%. Lung cancer clinical stage was I-II in 64.7% (55.3% Europe, 65.8% US).
共有1388名受试者参加了肺病变活检（1329；95.7%）、基准标记放置（272；19.6%）、染料标记（23；1.7%）和/或淋巴结活检（36；2.6%）。456名受试者同时进行了支气管内超声引导分期。全身麻醉（总体为78.2%、欧洲56.6%、美国81.4%）、放射状支气管内超声（50.6%、4.0%、57.4%）、荧光镜检查（85.0%、41.7%、91.0%）和快速现场评估使用（61.7%、17.3%、68.5%）在不同地区存在差异。气胸和支气管肺出血分别在4.7%和2.7%的受试者中发生（3.2%[主要终点]和1.7%需要干预或住院）。呼吸衰竭发生率为0.6%。诊断率为67.8%（范围61.9%-70.7%；欧洲55.2%，美国69.8%）。对恶性肿瘤的敏感性为62.6%。肺癌临床分期为I-II期的占64.7%（欧洲55.3%，美国65.8%）。
Conclusions 结论Despite a heterogeneous cohort and regional differences in procedural techniques, ENB demonstrates low complications and a 67.8% diagnostic yield while allowing biopsy, staging, fiducial placement, and dye marking in a single procedure.
尽管在手术技术上存在异质性队列和区域差异，但ENB显示出低并发症和67.8%的诊断率，同时允许在单个手术中进行活检、分期、基准点放置和染色标记。
电磁导航支气管镜（ENB）
电磁导航支气管镜（ENB）的临床应用研究【合集】 |
