Sarcoidosis
Conditions
Keywords
Sarcoidosis, Diagnosis, Non-caseating granulomas, BAL, EUS-FNA, EBUS-TBNA, TBLB
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 - 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
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1%) We consider the current standard for the diagnostics of sarcoidosis to be outdated, considering the clinical availability of endo-sonography.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.
Interventions
PROCEDUREEUS-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
PROCEDUREEBB + TBLB + BAL
EBB = Endobronchial biopsy TBLB = Transbronchial biopsy BAL = Bronchoalveolar lavage
Sponsors
Leiden University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The role of endosonography (EBUS/ EUS - FNA) in demonstrating non-caseating granulomas in comparison with conventional bronchoscopy (TBLB + EBB) | within a week |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of complications of both the endosonography and conventional bronchoscopic workup | within 30 days |
| The additional value of BAL, in relation to endosonography and conventional bronchoscopy (TBLB + EBB), in diagnosing sarcoidosis | 2 weeks |
| Assessment of patient preference for both the endosonographic and conventional bronchoscopic work-up. | within a week |
Countries
Belgium, Denmark, Germany, Netherlands, Poland, United Kingdom
Outcome results
None listed