Division of Pulmonary and Critical Care Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.
Division of Pulmonary Critical Care and Sleep Medicine, Brody School of Medicine, East Carolina University, Greenville, North Carolina.
J Thorac Oncol. 2022 Apr;17(4):519-531. doi: 10.1016/j.jtho.2021.12.008. Epub 2021 Dec 29.
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.
The NAVIGATE single-arm, pragmatic cohort study (NCT02410837) enrolled subjects at 37 academic and community sites in seven countries with prospective 24-month follow-up. Subjects underwent ENB using the superDimension navigation system versions 6.3 to 7.1. The prespecified primary end point was procedure-related pneumothorax requiring intervention or hospitalization.
A total of 1388 subjects were enrolled for lung lesion biopsy (1329; 95.7%), fiducial marker placement (272; 19.6%), dye marking (23; 1.7%), 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% United States), 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% United States). Sensitivity for malignancy was 62.6%. Lung cancer clinical stage was I to II in 64.7% (55.3% Europe, 65.8% United States).
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.
电磁导航支气管镜（ENB）是一种微创、图像引导的方法，可用于对肺部病变进行活检或定位治疗。然而，目前尚无研究报告从大型、多国家、可推广的队列中进行 24 个月的前瞻性随访。本研究采用无限制的、真实世界的观察性设计，评估了 ENB 的安全性、诊断率和使用模式。
NAVIGATE 单臂实用队列研究（NCT02410837）在 7 个国家的 37 个学术和社区站点入组受试者，前瞻性随访 24 个月。受试者使用 SuperDimension 导航系统版本 6.3 至 7.1 进行 ENB。主要终点是需要干预或住院治疗的与操作相关的气胸。
共 1388 例受试者进行了肺部病变活检（1329 例；95.7%）、放置基准标记物（272 例；19.6%）、染料标记（23 例；1.7%）或淋巴结活检（36 例；2.6%）。456 例受试者同时进行了经支气管内超声引导分期。全身麻醉（总体 78.2%，欧洲 56.6%，美国 81.4%）、径向经支气管内超声（50.6%，4.0%，57.4%）、透视（85.0%，41.7%，91.0%）和快速现场评估的使用率（61.7%，17.3%，68.5%）在不同地区有所不同。气胸和支气管肺出血分别发生在 4.7%和 2.7%的受试者中（3.2%[主要终点]和 1.7%需要干预或住院治疗）。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%）。恶性肿瘤的敏感性为 62.6%。肺癌临床分期为 I 期至 II 期的比例为 64.7%（欧洲 55.3%，美国 65.8%）。
尽管队列存在异质性，且不同地区的操作技术存在差异，但 ENB 显示出较低的并发症发生率和 67.8%的诊断率，同时允许在单次操作中进行活检、分期、基准标记物放置和染料标记。
