Diagnostic yield and safety of the ProCore versus the standard EBUS-TBNA needle in subjects with suspected sarcoidosis

Background : No randomized trial has compared the yield of the ProCore needle, a novel needle for endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration (TBNA), with standard needles. Research design and methods : Consecutive subjects with intrathoracic lymphadenopathy due to suspected sarcoidosis were randomized 1:1 to undergo EBUS-TBNA with either the 22-gauge ProCore (EchoTip-ProCore, Cook-Medical) or the 22-gauge standard (Vizishot, Olympus) needle. The primary outcome was the diagnostic sensitivity; the secondary outcomes included the number of adequate aspirates obtained and procedure-related complications. Results : We randomized 100 (mean age, 43.4 years; 53% women) subjects. Of the 84 subjects finally diagnosed with sarcoidosis, the sensitivity of EBUS-TBNA was higher with the ProCore (36/42, 85.7%) versus the standard needle (31/42, 73.8%), although not statistically significant (p = 0.18). We obtained adequate aspirates in 95.2% and 90.5% subjects in the ProCore and the standard needle groups, respectively (p = 0.68). One complication (transient hypoxemia) occurred in each group. There were two incidences of the ProCore needle getting bent during the procedure. Conclusions : We found no difference in the sensitivity, specimen adequacy, or safety of EBUS-TBNA when performed with the ProCore or the Olympus needle in subjects with sarcoidosis. Larger studies are required to confirm our findings.[clinicaltrials.gov: NCT03656003].