Trial for the Diagnosis of Sarcoidosis (GRANULOMA)
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||Procedure: EUS-FNA/EBUS-TBNA + BAL Procedure: EBB + TBLB + BAL||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Endosonography (EUS and EBUS) vs Conventional Bronchoscopy for the Diagnosis of Sarcoidosis: a Randomized Trial|
- 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 ]
|Study Start Date:||March 2009|
|Study Completion Date:||May 2012|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|