Ultrathin Bronchoscopy With Radial Endobronchial Ultrasound and Rapid On-Site Evaluation for the Diagnosis of Peripheral Pulmonary Lesions: A Multicenter Randomized Controlled Factorial Trial.

Sampling may be needed for some nodules.

一些结节可能需要采样。

Many new technologies are available to improve the diagnostic performance of bronchoscopy for the sampling of PPLs, but few comparative trials exist.

许多新技术可用于提高支气管镜对肺部周围病变（PPLs）采样的诊断性能，但比较试验很少。

The objective of this study was to compare the diagnostic performance of bronchoscopy with radial endobronchial ultrasound (rEBUS) using an ultrathin bronchoscope (BF-MP190F; Olympus) with a non-ultrathin bronchoscope and to compare the diagnostic performance of bronchoscopy with and without rapid on-site evaluation (ROSE).

本研究的目的是比较使用超细支气管镜（BF-MP190F；奥林巴斯）与非超细支气管镜进行支气管镜检查时，结合使用径向支气管内超声（rEBUS）的诊断性能，以及比较有无快速现场细胞学评估（ROSE）时支气管镜检查的诊断性能。

research_question

Does diagnostic performance differ between ultrathin and non-ultrathin bronchoscopes with rEBUS, and what impact does ROSE have on diagnostic performance of rEBUS?

使用rEBUS时，超薄支气管镜与非超薄支气管镜的诊断性能是否存在差异，以及ROSE对rEBUS诊断性能有何影响？

study_design_and_methods

This pragmatic, multicenter, 2 × 2 factorial, randomized controlled trialinvolved adult patients with PPLs (mean diameter < 5 cm) and radiographic stage N0 disease referred for bronchoscopy.

这项实用的、多中心的、2×2因素的、随机对照试验涉及了被转诊进行支气管镜检查的成人患者，这些患者的肺周围病变（平均直径小于5厘米）和放射学分期为N0疾病。

The study was powered to detect a 20% improvement in the primary outcome of difference in diagnostic yield (DY) between ultrathin and non-ultrathin bronchoscopes and between procedures with and without ROSE.

该研究旨在检测超薄支气管镜与非超薄支气管镜之间，以及有无ROSE（快速现场细胞学检查）的程序之间在主要结果指标——诊断效率（DY）上的20%的改善差异。

Secondary outcomes included sensitivity for malignancy, complications, and procedure duration.

次要结果包括对恶性肿瘤的敏感性、并发症以及程序持续时间。

Results

Of 215 patients assessed, 186 patients were randomized and 181 patients were analyzed.

在评估的215名患者中，有186名患者被随机分组，181名患者被分析。

Malignancy prevalencewas 84%.

恶性肿瘤的患病率为84%。

No significant differences in DY or sensitivity for malignancy were found between non-ultrathin and ultrathin bronchoscopes: 65.6% vs 58.2% (difference, -7.3%; P = .36) and 84.3% vs 74.3% (difference, -10.0%; P = .21), respectively.

在非超细和超细支气管镜之间，对于恶性肿瘤的检测率或敏感性没有显著差异：分别为65.6%对58.2%（差异，-7.3%；P = .36）和84.3%对74.3%（差异，-10.0%；P = .21）。

Similarly, no significant differences were observed with or without ROSE: 60.4% vs 63.5% (difference, -3.1%; P = .76) and 80.3% vs 78.3% (difference, 2.0%; P = .83), respectively.

同样地，有或没有ROSE的情况下，观察到的差异也不显著：分别为60.4%对63.5%（差异，-3.1%；P = .76）和80.3%对78.3%（差异，2.0%；P = .83）。

interpretation

We could not identify a difference in DY or sensitivity for malignancy for the diagnosis of PPLs between an ultrathin bronchoscope and a non-ultrathin bronchoscope and between ROSE and no ROSE.

我们未能识别出在诊断PPLs时，超细支气管镜与非超细支气管镜之间，以及ROSE与无ROSE之间在DY或恶性肿瘤敏感性方面的差异。

The study was underpowered to detect smaller but potentially clinically meaningful differences.

该研究缺乏足够的统计功效来检测较小但可能具有临床意义的差异。

clinical_trial_registration

ClinicalTrials.gov; No.: NCT03809169; URL: www.

ClinicalTrials.gov; 编号: NCT03809169; 网址: www.

clinicaltrials

gov.

五年总生存率为65%，95%置信区间为58-72%。