Trial for the Diagnosis of Sarcoidosis

Study Overview
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Brief Summary
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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
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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1%) We consider the current standard for the diagnostics of sarcoidosis to be outdated, considering the clinical availability of endo-sonography.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.

Official Title
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Endosonography (EUS and EBUS) vs Conventional Bronchoscopy for the Diagnosis of Sarcoidosis: a Randomized Trial

Conditions
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Sarcoidosis

Intervention / Treatment
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* Procedure: EUS-FNA/EBUS-TBNA + BAL
* Procedure: EBB + TBLB + BAL


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Endosonography arm | Procedure: EUS-FNA/EBUS-TBNA + BAL<br>* 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<br>|
| Active Comparator: B<br>Conventional bronchoscopy arm | Procedure: EBB + TBLB + BAL<br>* EBB = Endobronchial biopsy TBLB = Transbronchial biopsy BAL = Bronchoalveolar lavage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sarcoidosis, Diagnosis, Non-caseating granulomas, EUS-FNA, EBUS-TBNA, TBLB, BAL