Maekura Toshiya, Sugimoto Chikatoshi, Tamiya Akihiro, Saijo Nobuhiko, Naoki Yoko, Koba Taro, Kimura Yohei, Matsuda Yoshinobu, Kanazu Masaki, Takeuchi Naoko, Sasaki Yumiko, Naito Yujiro, Tsuji Taisuke, Sugawara Reiko, Kobayashi Takehiko, Nakao Keiko, Taniguchi Yoshihiko, Okishio Kyoichi, Omachi Naoki, Kasai Takahiko, Atagi Shinji
Department of Internal Medicine, National Hospital Organization Kinki-chuo Chest Medical Center, Sakai, Japan.
Department of Clinical Research Center, National Hospital Organization Kinki-chuo Chest Medical Center, Sakai, Japan.
J Thorac Dis. 2017 Jul;9(7):1930-1936. doi: 10.21037/jtd.2017.06.85.
The diagnostic yield of peripheral pulmonary lesions (PPLs) by flexible bronchoscopy (FB) is still insufficient. To improve the diagnostic yield of bronchoscopy, several techniques such as endobronchial ultrasound (EBUS), virtual bronchoscopic navigation (VBN), and rapid on-site evaluation (ROSE) have been examined. The primary purpose of the present study was to evaluate the usefulness of combining EBUS, VBN, and ROSE for diagnosing small PPLs.
Patients with PPLs 30 mm or less on chest computed tomography (CT) were prospectively enrolled. We determined the responsible bronchus for the target lesions using VBN before bronchoscopy was performed. EBUS and ROSE were performed during the examination to determine whether the bronchus and specimen were adequate. On the basis of previous studies, we assumed that the diagnostic yield of 85% among eligible patients would indicate potential usefulness, whereas, the diagnostic yield of 75% would indicate the lower limit of interest. The required number of patients was estimated as 45 for a one-sided α value of 0.2 and a β value of 0.8. The primary study endpoint was the diagnostic yield.
Between June 2014 and July 2015, we enrolled 50 patients in the present study, and we excluded 5 patients. The total diagnostic yield of 45 PPLs was 77.7%. In cases of lung cancer, the diagnostic yield was 84.2%. The sensitivity, specificity, positive predictive value, and negative predictive value of ROSE were 90.6%, 92.3%, 96.7%, and 80.0%, respectively. The diagnostic yield of PPLs from 20 to 30 mm was 87.5%, and the diagnostic yield of PPLs less than 20 mm was 66.7%. PPLs for which the probe was located within the lesion had the highest diagnostic yield.
We could not demonstrate usefulness for diagnosing small PPLs by combining EBUS, VBN, and ROSE. However, combining these techniques may be useful for diagnosing lung cancer.
柔性支气管镜检查（FB）对周围型肺病变（PPL）的诊断率仍然不足。为提高支气管镜检查的诊断率，已对多种技术进行了研究，如支气管内超声（EBUS）、虚拟支气管镜导航（VBN）和快速现场评估（ROSE）。本研究的主要目的是评估联合应用EBUS、VBN和ROSE诊断小PPL的有效性。
前瞻性纳入胸部计算机断层扫描（CT）显示PPL直径30mm及以下的患者。在进行支气管镜检查前，使用VBN确定目标病变的责任支气管。检查期间进行EBUS和ROSE，以确定支气管和标本是否合适。根据既往研究，我们假设符合条件的患者中诊断率达到85%表明可能有效，而诊断率达到75%表明感兴趣的下限。对于单侧α值为0.2和β值为0.8的情况，估计所需患者数量为45例。主要研究终点为诊断率。
2014年6月至2015年7月，本研究共纳入50例患者，排除5例。45个PPL的总诊断率为77.7%。在肺癌病例中，诊断率为84.2%。ROSE的敏感性、特异性、阳性预测值和阴性预测值分别为 90.6%、92.3%、96.7%和80.0%。直径20至30mm的PPL诊断率为87.5%，直径小于20mm的PPL诊断率为66.7%。探头位于病变内的PPL诊断率最高。
我们未能证明联合应用EBUS、VBN和ROSE对诊断小PPL有效。然而，联合这些技术可能对诊断肺癌有用。
