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经支气管针吸术在诊断肺门和纵隔淋巴结病变中的快速现场评估:一项随机试验。

Rapid on-site evaluation of transbronchial aspirates in the diagnosis of hilar and mediastinal adenopathy: a randomized trial.

机构信息

Thoracic Endoscopy and Pulmonology Unit, Maggiore Hospital, Bologna.

Pathology Unit, Maggiore Hospital, Bologna.

出版信息

Chest. 2011 Feb;139(2):395-401. doi: 10.1378/chest.10-1521. Epub 2010 Oct 28.

DOI:10.1378/chest.10-1521
PMID:21030491
Abstract

BACKGROUND

Rapid on-site evaluation (ROSE) of transbronchial needle aspirates has long been used during flexible bronchoscopy, but its usefulness in the diagnosis of hilar and mediastinal adenopathy is controversial. The aim of the present study was to evaluate the extent to which ROSE can be valuable in patients undergoing transbronchial needle aspiration (TBNA) for the diagnosis of hilar and mediastinal adenopathy.

METHODS

A total of 168 consecutive patients with enlarged lymph nodes were randomized to undergo TBNA with or without ROSE. The primary outcome measure of the study was the diagnostic yield of TBNA on a per-patient basis. Secondary outcome measures included the percentage of adequate specimens on a per-lymph node basis, the number of biopsy sites on a per-patient basis, and the complication rate of bronchoscopy on a per-patient basis.

RESULTS

We found no significant difference between the TBNA group and the ROSE group in terms of diagnostic yield (75.3% vs 78.3%, respectively; P = .64), and percentage of adequate specimens (86.5% vs 78.4%, respectively; P = .11). The median (interquartile range) number of biopsy sites was significantly lower in the ROSE group (1 [1-2] vs 2 [1-2], respectively; P = .0005). The complication rate of bronchoscopy was significantly lower in patients undergoing on-site review (6% vs 20%; P = .01), whereas the complication rate of TBNA was similar among the study groups.

CONCLUSIONS

ROSE of transbronchial aspirates from hilar and mediastinal nodes enables avoidance of additional biopsy without loss in diagnostic yield and reduces the complication rate of bronchoscopy.

TRIAL REGISTRY

ClinicalTrials.gov; No.: NCT00915330; URL: www.clinicaltrials.gov

摘要

背景

经支气管针吸活检术(TBNA)在柔性支气管镜检查中已长期用于快速现场评估(ROSE),但其在诊断肺门和纵隔淋巴结病中的作用仍存在争议。本研究旨在评估 ROSE 在诊断肺门和纵隔淋巴结病的经支气管针吸活检(TBNA)患者中的应用价值。

方法

168 例淋巴结肿大的连续患者被随机分为 ROSE 组和非 ROSE 组,分别进行 TBNA 和非 ROSE 组。本研究的主要观察指标为患者的 TBNA 诊断率。次要观察指标包括每例淋巴结的标本充足率、每例患者的活检部位数和每例患者的支气管镜检查并发症率。

结果

TBNA 组和 ROSE 组的诊断率(分别为 75.3%和 78.3%;P=.64)和标本充足率(分别为 86.5%和 78.4%;P=.11)均无显著差异。ROSE 组活检部位数中位数(四分位距)明显低于 ROSE 组(1[1-2]与 2[1-2],P=.0005)。ROSE 组支气管镜检查并发症发生率显著低于非 ROSE 组(6%与 20%,P=.01),而两组 TBNA 并发症发生率相似。

结论

ROSE 可避免对肺门和纵隔淋巴结抽吸物进行额外的活检,而不会降低诊断率,并降低支气管镜检查的并发症发生率。

试验注册

ClinicalTrials.gov;编号:NCT00915330;网址:www.clinicaltrials.gov

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