Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
304 participants
INTERVENTIONAL
2009-03-31
2012-05-31
Brief Summary
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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.
Detailed Description
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1. A clinical and radiological suspicion of sarcoidosis stage I/II.
2. A tissue diagnosis of disease-specific non-caseating granulomas.
3. Exclusion of possible alternative diagnoses as lung cancer or tuberculosis.
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We consider the current standard for the diagnostics of sarcoidosis to be outdated, considering the clinical availability of endo-sonography.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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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A
Endosonography arm
EUS-FNA/EBUS-TBNA + BAL
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
B
Conventional bronchoscopy arm
EBB + TBLB + BAL
EBB = Endobronchial biopsy TBLB = Transbronchial biopsy BAL = Bronchoalveolar lavage
Interventions
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EUS-FNA/EBUS-TBNA + BAL
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
EBB + TBLB + BAL
EBB = Endobronchial biopsy TBLB = Transbronchial biopsy BAL = Bronchoalveolar lavage
Eligibility Criteria
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Inclusion Criteria
* Age \> 18 years
* Both males and females
* Written informed consent is obtained.
Exclusion Criteria
* Löfgren's syndrome
* Inability to undergo fiberbronchoscopy, EBUS or EUS (e.g. respiratory insufficiency, esophageal stenosis
* Contraindications for a lung or nodal biopsy (e.g. coagulopathy, thrombocytopenia)
* Pregnancy
* Inability to obtain informed consent
18 Years
ALL
No
Sponsors
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Leiden University Medical Center
OTHER
Responsible Party
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M.B. von Bartheld
MB von Bartheld, MSc. PhD Student
Principal Investigators
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M B von Bartheld, MSc
Role: STUDY_DIRECTOR
Pulmonary Department, Leiden University Medical Center
J T Annema, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Pulmonary Department, Leiden University Medical Center
K F Rabe, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Pulmonary Department, Leiden University Medical Center
Locations
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Universitair Ziekenhuis Gent
Ghent, , Belgium
Gentofte Hospital Copenhagen
Hellerup, Copenhagen, Denmark
Thoraxklinik Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Hospital Grosshansdorf
Großhansdorf, Schleswig-Holstein, 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, Netherlands
Erasmus Medisch Centrum
Rotterdam, South Holland, 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, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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LUMC-GRANULOMA
Identifier Type: -
Identifier Source: org_study_id