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.


BACKGROUND
ClinicalTrials.gov Identifier: NCT00373555.
Tremblay
Alain
A
Division of Respiratory Medicine, University of Calgary, Calgary, AB, Canada. Electronic address: alain.tremblay@ucalgary.ca.
Stather
David R
DR
Division of Respiratory Medicine, University of Calgary, Calgary, AB, Canada.
MacEachern
Paul
P
Division of Respiratory Medicine, University of Calgary, Calgary, AB, Canada.
Khalil
Moosa
M
Department of Pathology and Laboratory Medicine, University of Calgary, Calgary, AB, Canada.
Field
Stephen K
SK
Division of Respiratory Medicine, University of Calgary, Calgary, AB, Canada.
D000046:Academic Medical Centers; D000328:Adult; D000368:Aged; D044963:Biopsy, Fine-Needle / Q000379:methods*; D001707:Biopsy, Needle / Q000379:methods; D001980:Bronchi / Q000000981:diagnostic imaging / Q000473:pathology; D001999:Bronchoscopy; D016001:Confidence Intervals; D019160:Endosonography / Q000379:methods*; D005260:Female; D006801:Humans; D008198:Lymph Nodes / Q000000981:diagnostic imaging / Q000473:pathology; D008206:Lymphatic Diseases / Q000000981:diagnostic imaging / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011336:Probability; D011446:Prospective Studies; D012507:Sarcoidosis / Q000175:diagnosis / Q000000981:diagnostic imaging* / Q000473:pathology*; D012680:Sensitivity and Specificity; D016037:Single-Blind Method