Diagnostic yield and safety of the 19-gauge vs 22-gauge EBUS-TBNA needle in subjects with sarcoidosis (GUESS).

BACKGROUND: Observational data suggest that the 19-gauge (G) needle for endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration (TBNA) offers a higher diagnostic yield in sarcoidosis than the 22-G needle. No randomized trial has compared the yield of the two needles.

METHODS: We randomized consecutive subjects with suspected sarcoidosis and enlarged thoracic lymph nodes to undergo EBUS-TBNA with either the 19-G or the 22-G needle. We compared the study groups for diagnostic sensitivity (primary outcome) assessed by the yield of granulomas in subjects finally diagnosed with sarcoidosis. We also compared the sample adequacy, difficulty performing the needle puncture assessed on a visual analog scale (VAS), the subject's cough intensity on an operator-rated VAS, and procedure-related complications (secondary outcomes).

RESULTS: We randomized 150 (mean age, 43.0 years; 55% women) subjects and diagnosed sarcoidosis in 116 subjects. The diagnostic sensitivity of the 19-G needle (45/60, 75.0%) was not higher (p=0.52) than the 22-G needle (39/56, 69.6%). We obtained adequate aspirates in 90.0% and 85.7% of subjects in the respective groups (p=0.48). The operators had greater difficulty puncturing lymph nodes with the 19-G needle (p=0.03), while operator-assessed cough intensity was similar in the groups (p=0.41). Transient hypoxemia was the only complication encountered during EBUS-TBNA (two subjects in either group).

CONCLUSIONS: We did not find the 19-G needle superior to the 22-G in diagnostic sensitivity, specimen adequacy, or safety of EBUS-TBNA in sarcoidosis. Puncturing the lymph nodes was more difficult with the 19-G needle.

TRIAL REGISTRATION: clinicaltrials.gov, NCT04770948.