锥形束 CT 引导下电磁导航支气管镜检查的高诊断率：一项随机比利时单中心研究的结果。
High diagnostic yield of electromagnetic navigation bronchoscopy performed under cone beam CT guidance: results of a randomized Belgian monocentric study.
机构信息
Department of Pneumology, Hôpital Erasme, Université Libre de Bruxelles, 808 Route de Lennik, 1070, Brussels, Belgium.
Department of Radiology, Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium.
出版信息
BMC Pulm Med. 2023 May 27;23(1):185. doi: 10.1186/s12890-023-02492-7.
BACKGROUND
With the increasing use of low dose CT scans, numerous pulmonary nodules are detected. As majority of them are benign, development of efficient non-surgical diagnostic intervention is mandatory. Electromagnetic navigation bronchoscopy (ENB) has been developed to reach difficult to access lesions. The aim of the present study was to compare the diagnostic yield of ENB procedures performed in a classical endoscopy suite or in a hybrid room equipped by a cone beam CT (CBCT).
METHODS
A monocentric randomized study was performed in the Erasme Hospital between January 2020 and December 2021. Lung nodules of maximum 30 mm of diameter were eligible. In both arms (endoscopy or CBCT suites), ENB, fluoroscopic guidance and a radial endobronchial ultrasound were used to reach the lesion. Then six trans-bronchial biopsies (TBB) and one trans-bronchial lung cryobiopsy (TBLC) were performed. Primary outcomes were the diagnostic yield and diagnostic accuracy of the procedure.
RESULTS
Forty-nine patients were randomized (24 in the endoscopy and 25 in the CBCT arms). The lesion size was 15,9 ± 4,6 mm and 16,6 ± 6,0 mm respectively (mean ± SD, p = NS). The diagnostic yield of ENB performed under CBCT guidance was 80% compared to 42% when performed in the endoscopy suite under standard fluoroscopic guidance (p < 0,05). Similarly, the diagnostic accuracy in the CBCT group was 87% compared to 54% for the endoscopy group (p < 0,05). Duration of the procedure in the CBCT and endoscopy arms was 80 ± 23 and 61 ± 13 min respectively (mean ± SD, p < 0,01). Performing TBLC in addition to TBB increased the diagnostic yield by 14% (17 and 12,5% in CBCT and endoscopy suites respectively, p = NS).
CONCLUSION
This study highlighted the additional value to perform ENB procedure under CBCT guidance for small size (less than 2 cm of diameter) pulmonary nodules.
TRIAL REGISTRATION
Clinical trial registration number: NCT05257382.
背景
随着低剂量 CT 扫描的广泛应用，大量的肺结节被发现。由于大多数结节是良性的，因此必须开发有效的非手术诊断干预措施。电磁导航支气管镜（ENB）的发展是为了到达难以到达的病变部位。本研究的目的是比较在传统内镜室或配备锥形束 CT（CBCT）的杂交室中进行 ENB 程序的诊断效果。
方法
这是一项 2020 年 1 月至 2021 年 12 月在 Erasme 医院进行的单中心随机研究。最大直径为 30mm 的肺结节符合条件。在两个臂（内镜或 CBCT 套房）中，使用 ENB、透视引导和径向支气管内超声到达病变部位。然后进行 6 次经支气管活检（TBB）和 1 次经支气管肺冷冻活检（TBLC）。主要结局是该程序的诊断效果和诊断准确性。
结果
49 名患者被随机分配（内镜组 24 例，CBCT 组 25 例）。病变大小分别为 15.9±4.6mm 和 16.6±6.0mm（平均值±标准差，p=NS）。在 CBCT 引导下进行 ENB 的诊断效果为 80%，而在标准透视引导下在内镜室进行 ENB 的诊断效果为 42%（p<0.05）。同样，CBCT 组的诊断准确性为 87%，而内镜组为 54%（p<0.05）。在 CBCT 和内镜组中，手术持续时间分别为 80±23 和 61±13 分钟（平均值±标准差，p<0.01）。在 TBB 的基础上进行 TBLC 可将诊断效果提高 14%（CBCT 和内镜室分别为 17%和 12.5%，p=NS）。
结论
本研究强调了在 CBCT 引导下对小尺寸（直径小于 2cm）肺结节进行 ENB 程序的附加价值。
试验注册
临床试验注册号：NCT05257382。
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