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Conventional Aspiration vs Biopsy Needle for Endosonography: the International Sarcoidosis Assessment (ISA) RCT
PDPI Sulawesi Selatan & Utara, 05 Sep 2019 06:17:43

Abstract

Introduction: EBUS and EUS(B) are increasingly used as the first diagnostic test to assess granulomas or epithelioid clusters in patients suspected for sarcoidosis. Granuloma assessment on cytological specimens obtained by conventional fine needle aspirations can be challenging for pathologists. It is postulated that biopsy needles (ProCore) allow tissue acquisition including core biopsies - in addition to the cytological aspirates - thereby increasing the granuloma detection rate.

Methods: A worldwide (13 hospitals in 9 countries) randomized clinical trial (NCT02540694). Patient with suspected sarcoidosis stage I and II underwent EBUS or EUS-B (EBUS scope in the esophagus) and were randomized between conventional 22 Gauge (22G) or the thinner 25G biopsy needle (ProCore). Granuloma detection rate and sample quality were study endpoints. Diagnosis at 6 months, including cytopathology, clinical and radiological follow-up was the reference standard.

Results: 322 patients were randomized: 162 patients for conventional 22 G needle and 160 patients for 25G biopsy needle. 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 119/162 (73%) for the conventional 22G and 117/160 (73%) for the 25G biopsy needles and independent of sampling route. No major complications occurred. Data for sample quality are pending.

Conclusion: 25G ProCore biopsy needles have a similar granuloma detection rate in patient with sarcoidosis type I and II compared to the conventional 22G needles.

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