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

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 endosono...

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Published in:	Respirology (Carlton, Vic.) Vol. 27; no. 2; pp. 152 - 160
Main Authors:	Crombag, Laurence M. M., Mooij‐Kalverda, Kirsten, Szlubowski, Artur, Gnass, Maciej, Tournoy, Kurt G., Sun, Jiayuan, Oki, Masahide, Ninaber, Maarten K., Steinfort, Daniel P., Jennings, Barton R., Liberman, Moishe, Bilaceroglu, Semra, Bonta, Peter I., Korevaar, Daniël A., Trisolini, Rocco, Annema, Jouke T.
Format:	Journal Article
Language:	English
Published:	Chichester, UK John Wiley & Sons, Ltd 01.02.2022 Wiley Subscription Services, Inc
Subjects:	bronchoscopy and interventional techniques Clinical trials Cytology Diagnosis diagnostic accuracy EBUS endoscopic ultrasound using the EBUS scope endosonography Esophagus EUS‐B Granuloma Granulomas Original ORIGINAL ARTICLES Patients Sampling Sarcoidosis Ultrasonic imaging Ultrasound diagnostic accuracy sarcoidosis EBUS EUS-B endoscopic ultrasound using the EBUS scope endosonography bronchoscopy and interventional techniques
ISSN:	1323-7799, 1440-1843, 1440-1843
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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. This global RCT in patients with suspected sarcoidosis stage I/II with an indication for endosonographic nodal sampling showed a similarly high granuloma detection rate and sensitivity for diagnosing sarcoidosis with endobronchial ultrasound versus endoscopic ultrasound‐B. The findings imply that both diagnostic tests (endobronchial/oesophageal) can be used safely and universally in suspected sarcoidosis patients.
AbstractList	This global RCT in patients with suspected sarcoidosis stage I/II with an indication for endosonographic nodal sampling showed a similarly high granuloma detection rate and sensitivity for diagnosing sarcoidosis with endobronchial ultrasound versus endoscopic ultrasound‐B. The findings imply that both diagnostic tests (endobronchial/oesophageal) can be used safely and universally in suspected sarcoidosis patients. 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. This global RCT in patients with suspected sarcoidosis stage I/II with an indication for endosonographic nodal sampling showed a similarly high granuloma detection rate and sensitivity for diagnosing sarcoidosis with endobronchial ultrasound versus endoscopic ultrasound‐B. The findings imply that both diagnostic tests (endobronchial/oesophageal) can be used safely and universally in suspected sarcoidosis patients. 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. 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.BACKGROUND AND OBJECTIVEEndosonography 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.METHODSGlobal (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.RESULTSA 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.CONCLUSIONGranuloma 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. Background and objectiveEndosonography 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.MethodsGlobal (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.ResultsA 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.ConclusionGranuloma 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.
Author	Oki, Masahide Mooij‐Kalverda, Kirsten Ninaber, Maarten K. Steinfort, Daniel P. Tournoy, Kurt G. Liberman, Moishe Korevaar, Daniël A. Trisolini, Rocco Crombag, Laurence M. M. Sun, Jiayuan Bilaceroglu, Semra Annema, Jouke T. Szlubowski, Artur Gnass, Maciej Jennings, Barton R. Bonta, Peter I.
AuthorAffiliation	9 Department of Respiratory Medicine Royal Melbourne Hospital Parkville Victoria Australia 13 Dr. Suat Seren Training and Research Hospital for Thoracic Medicine and Surgery Yenişehir Mahallesi Izmir Turkey 1 Department of Respiratory Medicine, Amsterdam UMC University of Amsterdam Amsterdam The Netherlands 11 Division of Thoracic Surgery University of Montreal, CR‐CHUM Montreal Québec Canada 3 Endoscopy Unit John Paul II Hospital Kraków Poland 6 Department of Respiratory Endoscopy and Interventional Pulmonology Shanghai Chest Hospital, Shanghai Jiao Tong University Shanghai China 2 Endoscopy Unit Pulmonary Hospital Zakopane Poland 7 Department of Respiratory Medicine National Hospital Organization Nagoya Medical Center Nagoya Japan 12 Department of Respiratory Medicine Health Sciences University Izmir Turkey 10 Department of Respiratory Medicine Monash Health Clayton Victoria Australia 4 Department of Respiratory Medicine Onze‐Lieve‐Vrouw Ziekenhuis Aalst Belgium 5 Faculty of Medicine and Health
AuthorAffiliation_xml	– name: 13 Dr. Suat Seren Training and Research Hospital for Thoracic Medicine and Surgery Yenişehir Mahallesi Izmir Turkey – name: 3 Endoscopy Unit John Paul II Hospital Kraków Poland – name: 10 Department of Respiratory Medicine Monash Health Clayton Victoria Australia – name: 4 Department of Respiratory Medicine Onze‐Lieve‐Vrouw Ziekenhuis Aalst Belgium – name: 11 Division of Thoracic Surgery University of Montreal, CR‐CHUM Montreal Québec Canada – name: 12 Department of Respiratory Medicine Health Sciences University Izmir Turkey – name: 1 Department of Respiratory Medicine, Amsterdam UMC University of Amsterdam Amsterdam The Netherlands – name: 5 Faculty of Medicine and Health Sciences Ghent University Ghent Belgium – name: 8 Department of Respiratory Medicine Leiden University Medical Center Leiden The Netherlands – name: 2 Endoscopy Unit Pulmonary Hospital Zakopane Poland – name: 7 Department of Respiratory Medicine National Hospital Organization Nagoya Medical Center Nagoya Japan – name: 14 Interventional Pulmonology Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica del Sacro Cuore Rome Italy – name: 6 Department of Respiratory Endoscopy and Interventional Pulmonology Shanghai Chest Hospital, Shanghai Jiao Tong University Shanghai China – name: 9 Department of Respiratory Medicine Royal Melbourne Hospital Parkville Victoria Australia
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Keywords	diagnostic accuracy sarcoidosis EBUS EUS-B endoscopic ultrasound using the EBUS scope endosonography bronchoscopy and interventional techniques
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PublicationTitle	Respirology (Carlton, Vic.)
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PublicationYear	2022
Publisher	John Wiley & Sons, Ltd Wiley Subscription Services, Inc
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Snippet	Background and objective Endosonography with intrathoracic nodal sampling is proposed as the single test with the highest granuloma detection rate in suspected... This global RCT in patients with suspected sarcoidosis stage I/II with an indication for endosonographic nodal sampling showed a similarly high granuloma... Endosonography with intrathoracic nodal sampling is proposed as the single test with the highest granuloma detection rate in suspected sarcoidosis stage I/II.... Background and objectiveEndosonography with intrathoracic nodal sampling is proposed as the single test with the highest granuloma detection rate in suspected...
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SubjectTerms	bronchoscopy and interventional techniques Clinical trials Cytology Diagnosis diagnostic accuracy EBUS endoscopic ultrasound using the EBUS scope endosonography Esophagus EUS‐B Granuloma Granulomas Original ORIGINAL ARTICLES Patients Sampling Sarcoidosis Ultrasonic imaging Ultrasound
Title	EBUS versus EUS‐B for diagnosing sarcoidosis: The International Sarcoidosis Assessment (ISA) randomized clinical trial
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Volume	27
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