Department of Respiratory Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
Endoscopy Unit, Pulmonary Hospital, Zakopane, Poland.
Respirology. 2022 Feb;27(2):152-160. doi: 10.1111/resp.14182. Epub 2021 Nov 17.
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.
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.
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.
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.
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。
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。
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。
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。
