Safety Management Committee, Japan Society for Respiratory Endoscopy, Tokyo, Japan.
Respir Res. 2013 May 10;14(1):50. doi: 10.1186/1465-9921-14-50.
With the recent widespread use of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), there have been occasional reports on complications associated with its use. Previous reviews on EBUS-TBNA have been limited to studies by skilled operators, thus the results may not always be applicable to recent clinical practice. To assess the safety of EBUS-TBNA for the staging and diagnosis of lung cancer in Japan, a nationwide survey on its current usage status and complications associated with its use was conducted by the Japan Society for Respiratory Endoscopy (JSRE).
A questionnaire about EBUS-TBNA performed between January 2011 and June 2012 was mailed to 520 JSRE-accredited facilities.
Responses were obtained from 455 facilities (87.5%). During the study period, EBUS-TBNA was performed in 7,345 cases in 210 facilities (46.2%) using a convex probe ultrasound bronchoscope, for 6,836 mediastinal and hilar lesions and 275 lung parenchymal lesions. Ninety complications occurred in 32 facilities. The complication rate was 1.23% (95% confidence interval, 0.97%-1.48%), with hemorrhage being the most frequent complication (50 cases, 0.68%). Infectious complications developed in 14 cases (0.19%) (Mediastinitis, 7; pneumonia, 4; pericarditis, 1; cyst infection, 1; and sepsis, 1). Pneumothorax developed in 2 cases (0.03%), one of which required tube drainage. Regarding the outcome of the cases with complications, prolonged hospitalization was observed in 14 cases, life-threatening conditions in 4, and death in 1 (severe cerebral infarction) (mortality rate, 0.01%). Breakage of the ultrasound bronchoscope occurred in 98 cases (1.33%) in 67 facilities (31.9%), and that of the puncture needle in 15 cases (0.20%) in 8 facilities (3.8%).
Although the complication rate associated with EBUS-TBNA was found to be low, severe complications, including infectious complications, were observed, and the incidence of device breakage was high. Since the use of EBUS-TBNA is rapidly expanding in Japan, an educational program for its safe performance should be immediately established.
随着支气管内超声引导经支气管针吸活检术(EBUS-TBNA)的广泛应用,偶尔会有报道与之相关的并发症。之前的 EBUS-TBNA 相关综述仅限于熟练操作者的研究,因此结果可能并不总是适用于最近的临床实践。为了评估 EBUS-TBNA 在日本肺癌分期和诊断中的安全性,日本呼吸内镜学会(JSRE)对其目前的使用情况及其使用相关并发症进行了一项全国性调查。
我们向 520 家 JSRE 认证机构邮寄了一份关于 2011 年 1 月至 2012 年 6 月期间进行的 EBUS-TBNA 的调查问卷。
在 210 家机构(46.2%)中,共有 455 家机构(87.5%)对 7345 例患者(210 家机构)进行了超声支气管镜下的凸探头 EBUS-TBNA,对 6836 个纵隔和肺门病变和 275 个肺实质病变进行了检查。在 32 家机构中,发生了 90 例并发症。并发症发生率为 1.23%(95%置信区间,0.97%-1.48%),其中出血最常见(50 例,0.68%)。发生了 14 例感染性并发症(0.19%)(纵隔炎 7 例,肺炎 4 例,心包炎 1 例,囊肿感染 1 例,败血症 1 例)。气胸发生在 2 例(0.03%),其中 1 例需要引流。关于有并发症的病例的结局,14 例患者住院时间延长,4 例出现危及生命的情况,1 例死亡(严重脑梗死)(死亡率为 0.01%)。在 67 家机构(31.9%)中,有 98 例(1.33%)发生了超声支气管镜断裂,在 8 家机构(3.8%)中发生了 15 例(0.20%)穿刺针断裂。
尽管 EBUS-TBNA 相关并发症的发生率较低,但仍观察到严重并发症,包括感染性并发症,且设备断裂的发生率较高。由于 EBUS-TBNA 在日本的应用迅速扩大,应立即建立其安全应用的教育项目。