Trial for the Diagnosis of Sarcoidosis (GRANULOMA)
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|ClinicalTrials.gov Identifier: NCT00872612|
Recruitment Status : Completed
First Posted : March 31, 2009
Last Update Posted : December 7, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoidosis||Procedure: EUS-FNA/EBUS-TBNA + BAL Procedure: EBB + TBLB + BAL||Phase 3|
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:
- A clinical and radiological suspicion of sarcoidosis stage I/II.
- A tissue diagnosis of disease-specific non-caseating granulomas.
- 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We consider the current standard for the diagnostics of sarcoidosis to be outdated, considering the clinical availability of endo-sonography.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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||304 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Endosonography (EUS and EBUS) vs Conventional Bronchoscopy for the Diagnosis of Sarcoidosis: a Randomized Trial|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||May 2012|
Procedure: 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
Active Comparator: B
Conventional bronchoscopy arm
Procedure: EBB + TBLB + BAL
EBB = Endobronchial biopsy TBLB = Transbronchial biopsy BAL = Bronchoalveolar lavage
- The role of endosonography (EBUS/ EUS - FNA) in demonstrating non-caseating granulomas in comparison with conventional bronchoscopy (TBLB + EBB) [ Time Frame: within a week ]
- Assessment of complications of both the endosonography and conventional bronchoscopic workup [ Time Frame: within 30 days ]
- The additional value of BAL, in relation to endosonography and conventional bronchoscopy (TBLB + EBB), in diagnosing sarcoidosis [ Time Frame: 2 weeks ]
- Assessment of patient preference for both the endosonographic and conventional bronchoscopic work-up. [ Time Frame: within a week ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00872612
|Universitair Ziekenhuis Gent|
|Gent, Belgium, 9000|
|Gentofte Hospital Copenhagen|
|Hellerup, Copenhagen, Denmark, 2900|
|Heidelberg, Baden-Württemberg, Germany, 69126|
|Grosshansdorf, Schleswig-Holstein, Germany, 22927|
|Arnhem, Gelderland, Netherlands|
|Radboud Universitair Medisch Centrum|
|Nijmegen, Gelderland, Netherlands|
|St. Catharina Ziekenhuis|
|Eindhoven, Noord-Brabant, Netherlands|
|Medisch Centrum Haaglanden|
|Den Haag, Zuid-Holland, Netherlands|
|Pulmonary Department, Leiden University Medical Center|
|Leiden, Zuid-Holland, Netherlands, 2300 RC|
|Erasmus Medisch Centrum|
|Rotterdam, Zuid-Holland, Netherlands, 3015 CE|
|St. Franciscus Ziekenhuis|
|Rotterdam, Zuid-Holland, Netherlands|
|University hospital Krakow, J.P. II|
|Sokołowski Pulmonary Hospital|
|Chelsea and Westminster hospital|
|London, United Kingdom, SW10 9NH|
|Royal Brompton Hospital|
|London, United Kingdom|
|Study Director:||M B von Bartheld, MSc||Pulmonary Department, Leiden University Medical Center|
|Principal Investigator:||J T Annema, MD PhD||Pulmonary Department, Leiden University Medical Center|
|Principal Investigator:||K F Rabe, MD PhD||Pulmonary Department, Leiden University Medical Center|