Randomized Study of Endobronchial Ultrasound-Guided Transbronchial Biopsy: Thin Bronchoscopic Method versus Guide Sheath Method

IntroductionIn endobronchial ultrasound-guided transbronchial biopsy (EBUS-TBB), techniques using a thin bronchoscope or a guide sheath have been proposed for accurate biopsy instrument reinsertion into the bronchial route indicated by a radial ultrasonic probe. The purpose of this study was to compare the diagnostic yields of these techniques for peripheral pulmonary lesions.MethodsPatients with suspected peripheral pulmonary lesions were included in this prospective, randomized, noninferiority study and assigned to undergo EBUS-TBB under fluoroscopic guidance using a prototype 3.4-mm thin bronchoscope or a 4.0-mm bronchoscope with a guide sheath.ResultsA total of 205 patients were enrolled and randomized, of whom 203 patients (101 thin bronchoscopic method; 102 guide sheath method) were included in the analysis. Diagnostic histologic specimens were obtained in 65% (41% for benign and 75% for malignant lesions) of the thin bronchoscopy group and 62% (25% for benign and 71% for malignant lesions) of the guide sheath group. Diagnostic performance of the thin bronchoscopic method was confirmed to be noninferior to the guide sheath method (difference in diagnostic yields, 3.6%; 90% confidence interval, −7.5 to 14.7%). Mean procedure time was significantly shorter in the thin bronchoscopy group than the guide sheath group (27 versus 33 minutes; p = 0.002). Complications including pneumothorax, moderate bleeding, and pneumonia occurred in 5% and 2% in the respective groups (p = 0.28).ConclusionsEBUS-TBB using the thin bronchoscope was noninferior to the guide sheath method for the diagnosis of peripheral pulmonary lesions and was associated with shorter procedural time.