Trial for the Diagnosis of Sarcoidosis
This trial is active, not recruiting.
|Treatments||eus-fna/ebus-tbna + bal, ebb + tblb + bal|
|Sponsor||Leiden University Medical Center|
|Start date||March 2009|
|End date||November 2011|
|Trial size||304 participants|
|Trial identifier||NCT00872612, LUMC-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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Gent, Belgium||Universitair Ziekenhuis Gent||no longer recruiting|
|Hellerup, Denmark||Gentofte Hospital Copenhagen||no longer recruiting|
|Heidelberg, Germany||Thoraxklinik Heidelberg||no longer recruiting|
|Grosshansdorf, Germany||Hospital Grosshansdorf||no longer recruiting|
|Arnhem, Netherlands||Rijnstaete Ziekenhuis||no longer recruiting|
|Nijmegen, Netherlands||Radboud Universitair Medisch Centrum||no longer recruiting|
|Eindhoven, Netherlands||St. Catharina Ziekenhuis||no longer recruiting|
|Den Haag, Netherlands||Medisch Centrum Haaglanden||no longer recruiting|
|Leiden, Netherlands||Pulmonary Department, Leiden University Medical Center||no longer recruiting|
|Rotterdam, Netherlands||St. Franciscus Ziekenhuis||no longer recruiting|
|Rotterdam, Netherlands||Erasmus Medisch Centrum||no longer recruiting|
|Krakow, Poland||University hospital Krakow, J.P. II||no longer recruiting|
|Zakopane, Poland||Sokołowski Pulmonary Hospital||no longer recruiting|
|London, United Kingdom||Royal Brompton Hospital||no longer recruiting|
|London, United Kingdom||Chelsea and Westminster hospital||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
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
Male or female participants at least 18 years old.
Inclusion Criteria: - Patients with suspected pulmonary sarcoidosis stage I/ II - Age > 18 years - Both males and females - Written informed consent is obtained. Exclusion Criteria: - Patients with obvious other organ involvement of sarcoidosis where a simple diagnostic biopsy to assess granulomas can be performed. - 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
|Official title||Endosonography (EUS and EBUS) vs Conventional Bronchoscopy for the Diagnosis of Sarcoidosis: a Randomized Trial|
|Principal investigator||J T Annema, MD PhD|
|Description||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: 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.|
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