A randomized controlled trial of standard vs endobronchial ultrasonography-guided transbronchial needle aspiration in patients with suspected sarcoidosis.

BACKGROUND Endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration (TBNA) of mediastinal lymph nodes has been found to be more accurate than standard TBNA in the setting of malignancy. In patients with suspected sarcoidosis, the smaller ultrasound needle may yield inadequate material to make a histologic diagnosis of granulomatous inflammation. The aim of this study was to compare the diagnostic yield of EBUS-guided TBNA to TBNA performed with a standard 19-gauge needle in patients with mediastinal adenopathy and a clinical suspicion of sarcoidosis. METHODS A randomized controlled trial was performed in a university medical center, enrolling 50 patients (of 61 screened, 2 declined, and 9 did not meet entry criteria) with hilar and/or mediastinal adenopathy and a clinical suspicion of sarcoidosis. Twenty-four patients were randomized to undergo EBUS-guided TBNA and 26 to undergo TBNA using a standard 19-gauge needle. RESULTS The primary outcome measure of diagnostic yield was 53.8% vs 83.3% in favor of the EBUS-guided TBNA group, an absolute increase of 29.5% (p < 0.05; 95% confidence interval [CI], 8.6 to 55.4%). After blinded research pathology review, diagnostic yield was 73.1% vs 95.8%, in favor of the EBUS-guided TBNA group, an absolute increase of 22.7% (p = 0.05; 95% CI, 1.9 to 42.2%). Sensitivity and specificity were 60.9% and 100%, respectively, in the standard TBNA group, and 83.3% and 100%, respectively, in the EBUS-guided TBNA group (absolute increase in sensitivity, 22.5%; p = 0.085; 95% CI, 3.2 to 44.9%). CONCLUSIONS The diagnostic yield of EBUS-guided TBNA is superior to TBNA using a standard 19-gauge needle for sampling of mediastinal lymph nodes in patients with a clinical suspicion of sarcoidosis. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT00373555.