Randomized study of endobronchial ultrasound-guided transbronchial biopsy: Thin bronchoscopic method versus guide sheath method

摘要

In 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. Methods: Patients 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. Results: A 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). Conclusions: EBUS-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.