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传统经支气管针吸活检术与支气管内超声引导下经支气管针吸活检术(无论有无现场快速评估)用于结节病诊断的随机对照试验

Conventional Transbronchial Needle Aspiration Versus Endobronchial Ultrasound-guided Transbronchial Needle Aspiration, With or Without Rapid On-Site Evaluation, for the Diagnosis of Sarcoidosis: A Randomized Controlled Trial.

作者信息

Madan Karan, Dhungana Ashesh, Mohan Anant, Hadda Vijay, Jain Deepali, Arava Sudheer, Pandey Ravindra M, Khilnani Gopi C, Guleria Randeep

机构信息

Departments of *Pulmonary Medicine and Sleep Disorders †Pathology ‡Biostatistics, All India Institute of Medical Sciences (AIIMS), New Delhi, India.

出版信息

J Bronchology Interv Pulmonol. 2017 Jan;24(1):48-58. doi: 10.1097/LBR.0000000000000339.

DOI:10.1097/LBR.0000000000000339
PMID:27984385
Abstract

BACKGROUND

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) as a standalone modality is superior to conventional TBNA (c-TBNA) for the diagnosis of sarcoidosis. However, the overall yield is not different if combined with endobronchial biopsy (EBB) and transbronchial lung biopsy (TBLB). The utility of rapid on-site evaluation (ROSE) in a comparative evaluation of EBUS-TBNA versus c-TBNA for the diagnosis of sarcoidosis has not been previously evaluated.

METHODS

Eighty patients with suspected sarcoidosis were randomized 1:1:1:1 into 4 groups: c-TBNA without ROSE (TBNA-NR), c-TBNA with ROSE (TBNA-R), EBUS-TBNA without ROSE (EBUS-NR), and EBUS-TBNA with ROSE (EBUS-R). EBB and TBLB were performed in all patients. Primary objective was detection of granulomas for combined procedure. Secondary objectives were individual procedure yields, sedation dose, and procedure duration. Patients without a diagnosis following c-TBNA subsequently underwent EBUS-TBNA.

RESULTS

A total of 74 patients were finally diagnosed with sarcoidosis. Overall, granuloma detection was not significantly different between the 4 groups (68% in TBNA-NR, 89% in TBNA-R, 84% in EBUS-NR, and 83% in EBUS-R groups, P=0.49). The yield of c-TBNA in the TBNA-NR group was lower compared with that in TBNA-R group and EBUS-TBNA in EBUS groups (32%, 72%, 68%, and 67% for TBNA-NR, TBNA-R, EBUS-NR, and EBUS-R groups, respectively, P=0.04). Additional 20% patients were diagnosed when EBUS-TBNA was performed following a nondiagnostic bronchoscopy procedure in the TBNA-NR group. Sedation requirement and procedure duration were significantly lower with c-TBNA as compared with EBUS-TBNA (P<0.001).

CONCLUSION

When performing TBNA in the setting of suspected sarcoidosis, we found c-TBNA with ROSE and EBUS-TBNA (with or without ROSE) to be superior to c-TBNA alone. Whether c-TBNA with ROSE is equivalent to EBUS-TBNA cannot be determined from our study due to small sample size/low power.

摘要

背景

作为一种独立的检查手段,支气管内超声引导下经支气管针吸活检术(EBUS-TBNA)在结节病的诊断方面优于传统经支气管针吸活检术(c-TBNA)。然而,若联合支气管内活检(EBB)和经支气管肺活检(TBLB),总体诊断率并无差异。此前尚未评估快速现场评估(ROSE)在比较EBUS-TBNA与c-TBNA诊断结节病中的作用。

方法

80例疑似结节病患者按1:1:1:1随机分为4组:无ROSE的c-TBNA组(TBNA-NR)、有ROSE的c-TBNA组(TBNA-R)、无ROSE的EBUS-TBNA组(EBUS-NR)和有ROSE的EBUS-TBNA组(EBUS-R)。所有患者均接受EBB和TBLB。主要目标是联合检查中肉芽肿的检出情况。次要目标是各检查方法的诊断率、镇静剂量和操作时间。c-TBNA检查后未明确诊断的患者随后接受EBUS-TBNA检查。

结果

共有74例患者最终被诊断为结节病。总体而言,4组之间肉芽肿检出率无显著差异(TBNA-NR组为68%,TBNA-R组为89%,EBUS-NR组为84%,EBUS-R组为83%,P = 0.49)。TBNA-NR组的c-TBNA诊断率低于TBNA-R组以及EBUS组中的EBUS-TBNA诊断率(TBNA-NR组、TBNA-R组、EBUS-NR组和EBUS-R组分别为32%、72%、68%和67%,P = 0.04)。在TBNA-NR组中,非诊断性支气管镜检查后进行EBUS-TBNA时,另有20%的患者得到诊断。与EBUS-TBNA相比,c-TBNA的镇静需求和操作时间显著更低(P < 0.001)。

结论

在疑似结节病的情况下进行TBNA时,我们发现有ROSE的c-TBNA和EBUS-TBNA(有或无ROSE)均优于单独的c-TBNA。由于样本量小/检验效能低,我们的研究无法确定有ROSE的c-TBNA是否等同于EBUS-TBNA。

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