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This randomized study investigates two different diagnostic strategies for patients with suspected pulmonary sarcoidosis stage I/II.
The objective is to assess the role of endosonography (EBUS/ EUS - FNA) in demonstrating non-caseating granulomas in comparison with conventional bronchoscopy (TBLB + EBB).
Also the researchers investigate the additional value of BAL, in relation to endosonography and conventional bronchoscopy (TBLB + EBB), in diagnosing sarcoidosis.
Thirdly the researchers aim to assess the rate of complications in both the endosonography and conventional bronchoscopic workup.
Sarcoidosis is the most prevalent interstitial lung disease in Western-Europe and the US. The disease is most prevalent in young adults. To set the final diagnosis of sarcoidosis, the following parameters need to be present:
Nowadays, a bronchoscopy with lung biopsies is advised to set a tissue diagnosis of sarcoidosis. However, these biopsies are only diagnostic in 70% of the procedures and they are associated with a 3% risk of coughing up blood and a 4% risk of a lung collapse.
Since recently, a new diagnostic procedure has come available. This procedure, endo-sonography, makes it possible to biopsy lymph nodes in the chest under direct visualization and has a diagnostic accuracy of 85%. The associated risk of complications appears to be small (<1%)
We consider the current standard for the diagnostics of sarcoidosis to be outdated, considering the clinical availability of endo-sonography. We expect that endo-sonography is more frequent diagnostic for a tissue diagnosis of sarcoidosis.
Also we hypothesize that this technique is safer and more preferred by patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Endosonography arm |
|
| B | Active Comparator | Conventional bronchoscopy arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EUS-FNA/EBUS-TBNA + BAL | Procedure | EUS-FNA = Endoscopic Ultrasound guided fine needle aspiration of mediastinal lymph nodes. EBUS-TBNA = Endobronchial Ultrasound guided transbronchial needle aspiration of mediastinal and hilar lymph nodes. BAL = bronchoalveolar lavage |
| Measure | Description | Time Frame |
|---|---|---|
| The role of endosonography (EBUS/ EUS - FNA) in demonstrating non-caseating granulomas in comparison with conventional bronchoscopy (TBLB + EBB) | within a week |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of complications of both the endosonography and conventional bronchoscopic workup | within 30 days | |
| The additional value of BAL, in relation to endosonography and conventional bronchoscopy (TBLB + EBB), in diagnosing sarcoidosis | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M B von Bartheld, MSc | Pulmonary Department, Leiden University Medical Center | Study Director |
| J T Annema, MD PhD | Pulmonary Department, Leiden University Medical Center | Principal Investigator |
| K F Rabe, MD PhD | Pulmonary Department, Leiden University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Gent | Ghent | 9000 | Belgium | |||
| Gentofte Hospital Copenhagen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10573213 | Background | Costabel U, Hunninghake GW. ATS/ERS/WASOG statement on sarcoidosis. Sarcoidosis Statement Committee. American Thoracic Society. European Respiratory Society. World Association for Sarcoidosis and Other Granulomatous Disorders. Eur Respir J. 1999 Oct;14(4):735-7. doi: 10.1034/j.1399-3003.1999.14d02.x. No abstract available. | |
| 18032765 |
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| ID | Term |
|---|---|
| D012507 | Sarcoidosis |
| D004194 | Disease |
| ID | Term |
|---|---|
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006968 | Hypersensitivity, Delayed |
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| EBB + TBLB + BAL | Procedure | EBB = Endobronchial biopsy TBLB = Transbronchial biopsy BAL = Bronchoalveolar lavage |
|
| Assessment of patient preference for both the endosonographic and conventional bronchoscopic work-up. | within a week |
| Hellerup |
| Copenhagen |
| 2900 |
| Denmark |
| Thoraxklinik Heidelberg | Heidelberg | Baden-Wurttemberg | 69126 | Germany |
| Hospital Grosshansdorf | Großhansdorf | Schleswig-Holstein | 22927 | Germany |
| Rijnstaete Ziekenhuis | Arnhem | Gelderland | Netherlands |
| Radboud Universitair Medisch Centrum | Nijmegen | Gelderland | Netherlands |
| St. Catharina Ziekenhuis | Eindhoven | North Brabant | Netherlands |
| Pulmonary Department, Leiden University Medical Center | Leiden | South Holland | 2300 RC | Netherlands |
| Erasmus Medisch Centrum | Rotterdam | South Holland | 3015 CE | Netherlands |
| St. Franciscus Ziekenhuis | Rotterdam | South Holland | Netherlands |
| Medisch Centrum Haaglanden | The Hague | South Holland | Netherlands |
| University hospital Krakow, J.P. II | Krakow | Poland |
| Sokołowski Pulmonary Hospital | Zakopane | Poland |
| Royal Brompton Hospital | London | London | United Kingdom |
| Chelsea and Westminster hospital | London | SW10 9NH | United Kingdom |
| Iannuzzi MC, Rybicki BA, Teirstein AS. Sarcoidosis. N Engl J Med. 2007 Nov 22;357(21):2153-65. doi: 10.1056/NEJMra071714. No abstract available. |
| 8339618 | Background | Winterbauer RH, Lammert J, Selland M, Wu R, Corley D, Springmeyer SC. Bronchoalveolar lavage cell populations in the diagnosis of sarcoidosis. Chest. 1993 Aug;104(2):352-61. doi: 10.1378/chest.104.2.352. |
| 9493649 | Background | Kantrow SP, Meyer KC, Kidd P, Raghu G. The CD4/CD8 ratio in BAL fluid is highly variable in sarcoidosis. Eur Respir J. 1997 Dec;10(12):2716-21. doi: 10.1183/09031936.97.10122716. |
| 15738281 | Background | Annema JT, Veselic M, Rabe KF. Endoscopic ultrasound-guided fine-needle aspiration for the diagnosis of sarcoidosis. Eur Respir J. 2005 Mar;25(3):405-9. doi: 10.1183/09031936.05.00098404. |
| 17890467 | Background | Garwood S, Judson MA, Silvestri G, Hoda R, Fraig M, Doelken P. Endobronchial ultrasound for the diagnosis of pulmonary sarcoidosis. Chest. 2007 Oct;132(4):1298-304. doi: 10.1378/chest.07-0998. Epub 2007 Sep 21. |
| 23780458 | Derived | von Bartheld MB, Dekkers OM, Szlubowski A, Eberhardt R, Herth FJ, in 't Veen JC, de Jong YP, van der Heijden EH, Tournoy KG, Claussen M, van den Blink B, Shah PL, Zoumot Z, Clementsen P, Porsbjerg C, Mauad T, Bernardi FD, van Zwet EW, Rabe KF, Annema JT. Endosonography vs conventional bronchoscopy for the diagnosis of sarcoidosis: the GRANULOMA randomized clinical trial. JAMA. 2013 Jun 19;309(23):2457-64. doi: 10.1001/jama.2013.5823. |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |