Status:
COMPLETED
Trial for the Diagnosis of Sarcoidosis
Lead Sponsor:
Leiden University Medical Center
Conditions:
Sarcoidosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 -...
Detailed 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 parame...
Eligibility Criteria
Inclusion
- Patients with suspected pulmonary sarcoidosis stage I/ II
- Age \> 18 years
- Both males and females
- Written informed consent is obtained.
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT00872612
Start Date
March 1 2009
End Date
May 1 2012
Last Update
December 7 2015
Active Locations (15)
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1
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
2
Gentofte Hospital Copenhagen
Hellerup, Copenhagen, Denmark, 2900
3
Thoraxklinik Heidelberg
Heidelberg, Baden-Wurttemberg, Germany, 69126
4
Hospital Grosshansdorf
Großhansdorf, Schleswig-Holstein, Germany, 22927