EBUS versus EUS-B for diagnosing sarcoidosis: The International Sarcoidosis Assessment (ISA) randomized clinical trial

Laurence M M Crombag, Kirsten Mooij-Kalverda, Artur Szlubowski, Maciej Gnass, Kurt G Tournoy, Jiayuan Sun, Masahide Oki, Maarten K Ninaber, Daniel P Steinfort, Barton R Jennings, Moishe Liberman, Semra Bilaceroglu, Peter I Bonta, Daniël A Korevaar, Rocco Trisolini, Jouke T Annema, Laurence M M Crombag, Kirsten Mooij-Kalverda, Artur Szlubowski, Maciej Gnass, Kurt G Tournoy, Jiayuan Sun, Masahide Oki, Maarten K Ninaber, Daniel P Steinfort, Barton R Jennings, Moishe Liberman, Semra Bilaceroglu, Peter I Bonta, Daniël A Korevaar, Rocco Trisolini, Jouke T Annema

Abstract

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.

Trial registration: ClinicalTrials.gov NCT02540694.

Keywords: EBUS; EUS-B; bronchoscopy and interventional techniques; diagnostic accuracy; endoscopic ultrasound using the EBUS scope; endosonography; sarcoidosis.

Conflict of interest statement

This is an investigator‐initiated study. The institution received a financial contribution for the database and a PhD student from Cook Medical. The institutions purchased the needles used in this study for a reduced fee. The complete design, execution, analysis and presentation of results were performed by the investigators without any input from Cook Medical or any other external party. The individual investigators made no other disclosures.

© 2021 The Authors. Respirology published by John Wiley & Sons Australia, Ltd on behalf of Asian Pacific Society of Respirology.

Figures

FIGURE 1
FIGURE 1
Flow diagram of enrolment and intervention in the International Sarcoidosis Assessment (ISA) trial. aOne patient refused endoscopy after randomization and was excluded from analysis. bSeventeen patients did not complete the study: three due to death and 14 lost to follow‐up

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