Division of Thoracic Surgery, Toronto General Hospital, University Health Network, University of Toronto, Toronto, Ontario, Canada.
J Thorac Cardiovasc Surg. 2011 Dec;142(6):1393-400.e1. doi: 10.1016/j.jtcvs.2011.08.037. Epub 2011 Oct 2.
The study objective was to compare endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) with mediastinoscopy for mediastinal lymph node staging of potentially resectable non-small cell lung cancer.
Patients with confirmed or suspected non-small cell lung cancer who required mediastinoscopy to determine suitability for lung cancer resection were entered into the trial. All patients underwent EBUS-TBNA followed by mediastinoscopy under general anesthesia. If both were negative for N2 or N3 disease, the patient underwent pulmonary resection and mediastinal lymphadenectomy.
Between July 2006 and August 2010, 190 patients were registered in the study, 159 enrolled, and 153 were eligible for analysis. EBUS-TBNA and mediastinoscopy sampled an average of 3 and 4 lymph node stations per patient, respectively. The mean short axis of the lymph node biopsied by EBUS-TBNA was 6.9 ± 2.9 mm. The prevalence of N2/N3 disease was 35% (53/153). There was excellent agreement between EBUS-TBNA and mediastinoscopy for mediastinal staging in 136 patients (91%; Kappa, 0.8; 95% confidence interval, 0.7-0.9). Specificity and positive predictive value for both techniques were 100%. The sensitivity, negative predictive value, and diagnostic accuracy for mediastinal lymph node staging for EBUS-TBNA and mediastinoscopy were 81%, 91%, 93%, and 79%, 90%, 93%, respectively. No significant differences were found between EBUS-TBNA and mediastinoscopy in determining the true pathologic N stage (McNemar's test, P = .78). There were no complications from EBUS-TBNA. Minor complications from mediastinoscopy were observed in 4 patients (2.6%).
EBUS-TBNA and mediastinoscopy achieve similar results for the mediastinal staging of lung cancer. As performed in this study, EBUS-TBNA can replace mediastinoscopy in patients with potentially resectable non-small cell lung cancer.
本研究旨在比较支气管内超声引导经支气管针吸活检术（EBUS-TBNA）与纵隔镜检查在可切除性非小细胞肺癌纵隔淋巴结分期中的作用。
本试验纳入了需要纵隔镜检查以确定是否适合进行肺癌切除术的确诊或疑似非小细胞肺癌患者。所有患者均在全身麻醉下接受 EBUS-TBNA 检查，然后接受纵隔镜检查。如果两者均未发现 N2 或 N3 疾病，则患者接受肺切除术和纵隔淋巴结清扫术。
2006 年 7 月至 2010 年 8 月，共有 190 例患者登记入组，其中 159 例患者纳入研究，153 例患者符合分析标准。EBUS-TBNA 和纵隔镜检查分别对每位患者平均采样 3 个和 4 个淋巴结站。EBUS-TBNA 活检的淋巴结短轴平均为 6.9 ± 2.9mm。153 例患者中 N2/N3 疾病的发生率为 35%（53/153）。在 136 例患者中，EBUS-TBNA 和纵隔镜检查对纵隔分期的结果具有极好的一致性（91%；Kappa 值，0.8；95%置信区间，0.7-0.9）。两种技术的特异性和阳性预测值均为 100%。EBUS-TBNA 和纵隔镜检查对纵隔淋巴结分期的敏感性、阴性预测值和诊断准确性分别为 81%、91%、93%和 79%、90%、93%。EBUS-TBNA 和纵隔镜检查在确定真实病理 N 分期方面无显著差异（McNemar 检验，P=0.78）。EBUS-TBNA 无并发症发生。纵隔镜检查有 4 例（2.6%）发生轻微并发症。
EBUS-TBNA 和纵隔镜检查在肺癌纵隔分期方面具有相似的结果。在本研究中，EBUS-TBNA 可替代纵隔镜检查用于可切除性非小细胞肺癌患者。
