EBUS vs EUS-B for diagnosing sarcoidosis: The international sarcoidosis assessment (ISA) RCT.

Introduction: Endosonography with intrathoracic nodal sampling is the single test with the highest diagnostic yield in suspected sarcoidosis. However, the optimal nodal sampling route; either the endobronchial (EBUS) or the transesophageal approach (EUS-B) is under debate. Method(s): A global (4 continents, 9 countries) randomized clinical trial (NCT02540694). Patients with suspected sarcoidosis stage I and II were included and randomized to EBUS or EUS-B and to conventional 22 Gauge aspiration needle or 25G biopsy needle (ProCore). Granuloma detection rate, sensitivity for diagnosing sarcoidosis and procedural operator feasibility (scale 1(not feasible) to 5(very feasible)) were study endpoints. The final diagnosis was based on cytology outcomes, clinical and radiological at 6 months follow-up. Result(s): 322 patients were randomized: 167 patients to EBUS-TBNA and 155 to EUS-B-FNA. Final diagnoses were: sarcoidosis (n=272, 85%), lymphoma (n=7, 2%), (N)SCLC (n=6, 2%), TBC (n=2, 0.5%), other e.g. postinflammation/reactive mediastinal nodal disease (n=35, 10.5%). Granuloma detection rate was 73% overall and 75% for EBUSTBNA and 70.3% for EUS-B-FNA and independent of needle type. Sensitivity of endosonography for diagnosing sarcoidosis was 85% overall, 84% for EBUS and 87% for EUSB. No major complications, specifically no mediastinitis/abcess formation occurred. Mean feasibility score was 4.4 for EUS-B and 4.3 EBUS (p=0.215). Conclusion(s): Endosonography with nodal sampling is safe, feasible and has a high granuloma detecting rate and sensitivity for diagnosing stage I / II sarcoidosis, which is independent of the sampling route (endobronchial vs transesophageal).