经支气管超声内镜检查（EBUS）与超声内镜引导下细针抽吸活检（EUS-B）诊断结节病：国际结节病评估（ISA）随机临床试验。
EBUS versus EUS-B for diagnosing sarcoidosis: The International Sarcoidosis Assessment (ISA) randomized clinical trial.
机构信息
Department of Respiratory Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
Endoscopy Unit, Pulmonary Hospital, Zakopane, Poland.
出版信息
Respirology. 2022 Feb;27(2):152-160. doi: 10.1111/resp.14182. Epub 2021 Nov 17.
BACKGROUND AND OBJECTIVE
Endosonography with intrathoracic nodal sampling is proposed as the single test with the highest granuloma detection rate in suspected sarcoidosis stage I/II. However, most studies have been performed in limited geographical regions. Studies suggest that oesophageal endosonographic nodal sampling has higher diagnostic yield than endobronchial endosonographic nodal sampling, but a head-to-head comparison of both routes has never been performed.
METHODS
Global (14 hospitals, nine countries, four continents) randomized clinical trial was conducted in consecutive patients with suspected sarcoidosis stage I/II presenting between May 2015 and August 2017. Using an endobronchial ultrasound (EBUS) scope, patients were randomized to EBUS or endoscopic ultrasound (EUS)-B-guided nodal sampling, and to 22- or 25-G ProCore needle aspiration (2 × 2 factorial design). Granuloma detection rate was the primary study endpoint. Final diagnosis was based on cytology/pathology outcomes and clinical/radiological follow-up at 6 months.
RESULTS
A total of 358 patients were randomized: 185 patients to EBUS-transbronchial needle aspiration (EBUS-TBNA) and 173 to EUS-B-fine-needle aspiration (FNA). Final diagnosis was sarcoidosis in 306 patients (86%). Granuloma detection rate was 70% (130/185; 95% CI, 63-76) for EBUS-TBNA and 68% (118/173; 95% CI, 61-75) for EUS-B-FNA (p = 0.67). Sensitivity for diagnosing sarcoidosis was 78% (129/165; 95% CI, 71-84) for EBUS-TBNA and 82% (115/141; 95% CI, 74-87) for EUS-B-FNA (p = 0.46). There was no significant difference between the two needle types in granuloma detection rate or sensitivity.
CONCLUSION
Granuloma detection rate of mediastinal/hilar nodes by endosonography in patients with suspected sarcoidosis stage I/II is high and similar for EBUS and EUS-B. These findings imply that both diagnostic tests can be safely and universally used in suspected sarcoidosis patients.
背景与目的
经胸超声内镜（endosonography with intrathoracic nodal sampling）联合纵隔/肺门淋巴结取样被认为是疑似 I/II 期结节病患者中肉芽肿检测率最高的单项检测方法。然而，大多数研究都集中在有限的地理区域内进行。研究表明，食管超声内镜（endoscopic ultrasound，EUS）下淋巴结取样的诊断率高于支气管内超声内镜（endobronchial ultrasound，EBUS）下淋巴结取样，但这两种方法尚未进行过直接比较。
方法
这是一项在全球范围内（14 家医院，9 个国家，四大洲）进行的连续疑似 I/II 期结节病患者的前瞻性、随机临床试验，于 2015 年 5 月至 2017 年 8 月期间入组患者。采用支气管内超声内镜（EBUS）探头，将患者随机分配至 EBUS 或内镜超声（EUS）-B 引导下的淋巴结取样，并采用 22 或 25-G ProCore 针抽吸（2×2 析因设计）。肉芽肿检测率是主要研究终点。最终诊断基于细胞学/病理学结果，以及 6 个月时的临床/放射学随访。
结果
共纳入 358 例患者，其中 185 例患者接受 EBUS 经支气管针吸活检（EBUS-TBNA），173 例患者接受 EUS-B 细针抽吸（EUS-B-FNA）。最终诊断为结节病的患者共 306 例（86%）。EBUS-TBNA 的肉芽肿检测率为 70%（130/185；95%可信区间，63-76），EUS-B-FNA 的肉芽肿检测率为 68%（118/173；95%可信区间，61-75）（p=0.67）。EBUS-TBNA 诊断结节病的敏感性为 78%（129/165；95%可信区间，71-84），EUS-B-FNA 的敏感性为 82%（115/141；95%可信区间，74-87）（p=0.46）。两种针型的肉芽肿检测率或敏感性无显著差异。
结论
在疑似 I/II 期结节病患者中，经胸超声内镜检查对纵隔/肺门淋巴结的肉芽肿检测率较高，且 EBUS 和 EUS-B 结果相似。这些发现表明，这两种诊断方法都可以安全且普遍地应用于疑似结节病患者。
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