EBUS vs EUS-B for Diagnosing Sarcoidosis

Study Overview
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Brief Summary
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Rationale: Endosonography with mediastinal/ hilar nodal sampling is the test of choice to diagnose sarcoidosis stage I and II - in case tissue verification of noncaseating granulomas is indicated. However, the optimal endosonographic approach (endobronchial or transoesophageal) for mediastinal nodal sampling is under discussion. Secondly, which needle size or type provides optimal tissue sample quality for granuloma detection is unknown. The novel 25 Gauge (G) beveled ProCore needle, allows tissue acquisition of small core biopsies in addition to cytological aspirates. Hypotheses: Esophageal ultrasound guided (EUS-B) sampling of intrathoracic lymph nodes has a 14% higher granuloma detection rate compared to endobronchial ultrasound (EBUS) guided nodal sampling in patients with suspected sarcoidosis stage I/II. 25G ProCore needles provide superior sample quality compared to conventional 22G needles in patients with suspected sarcoidosis stage I/II. Study design: Investigator initiated, randomized clinical trial. Setting: International, multicenter (university and general hospitals) Study population: Consecutive patients with a clinical and radiologic suspicion of sarcoidosis stage I or II and an indication for tissue verification of non-caseating granulomas are eligible for inclusion. Intervention: EBUS vs EUS-B, simultaneously comparing the standard vs novel ProCore needles. Main study endpoints: The granuloma detection rate of endobronchial (EBUS) guided sampling of intrathoracic lymph nodes compared to esophageal (EUS-B using the EBUS scope) guided sampling in patients with suspected sarcoidosis stage I/II. Sample quality of conventional 22G vs. 25G ProCore needles in patients with suspected sarcoidosis stage I/II.

Official Title
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Endobronchial vs. Esophageal Ultrasound for Diagnosing Sarcoidosis: A Randomized Clinical Trial; - A Standard vs. - ProCore Needle Comparison -

Conditions
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Sarcoidosis, Endosonography

Intervention / Treatment
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* Device: Endosonography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical and radiologic suspicion of sarcoidosis stage I (mediastinal or hilar lymphadenopathy) or stage II (lymphadenopathy and interparenchymal abnormalities) Indication for tissue verification of noncaseating granuloma's Provision of a written informed consent Exclusion Criteria: Life expectancy of less than 6 months Obvious organ involvement of sarcoidosis with the possibility to confirm granulomas with a minimally invasive diagnostic procedure (eg skin lesion or superficial lymph node) Positive acid-fast bacilli sputum test Contra-indication for endosonography Pregnancy

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: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EBUS-TBNA using 22G needle<br>EBUS-TBNA using 22G needle (transbronchial route) | Device: Endosonography<br> <br> * Other names: EUS-B;|
| Active Comparator: EBUS-TBNA using 25G ProCore needle<br>EBUS-TBNA using 25G ProCore needle (transbronchial route) | Device: Endosonography<br> <br> * Other names: EUS-B;|
| Active Comparator: EUS-B-FNA using 22G needle<br>EUS-B-FNA using 22G needle (transoesophageal route) | Device: Endosonography<br> <br> * Other names: EUS-B;|
| Active Comparator: EUS-B-FNA using 25G ProCOre needle<br>EUS-B-FNA using 25G ProCOre needle (transoesophageal route) | Device: Endosonography<br> <br> * Other names: EUS-B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The granuloma detection rate of endobronchial (EBUS) guided sampling of intrathoracic lymph nodes compared to esophageal (EUS-B using the EBUS scope) guided sampling in patients with suspected sarcoidosis stage I/II. |  | 2 weeks after the endosonography procedure. | 
| Sample quality of conventional 22G vs. 25G ProCore needles in patients with suspected sarcoidosis stage I/II. | The sample quality will be assessed by two independent reference pathologists. The performance of each needle (25 ProCore / standard 22 G) will be scored on five items (the modified Mair score). | 9 months after inclusion of last patient. |