Guide sheath versus non-guide sheath method for endobronchial ultrasound-guided biopsy of peripheral pulmonary lesions: A multicenter randomized trial.

INTRODUCTION Guide sheaths (GSs) have been widely used during radial probe endobronchial ultrasound-guided transbronchial biopsy (rEBUS-TBB) of peripheral pulmonary lesions. However, it remains unknown whether a GS enhances the diagnostic yield. We compared the diagnostic yields of small peripheral pulmonary lesions between rEBUS-TBB with and without a GS. METHODS In eight institutions, patients with peripheral pulmonary lesions≤30 mm in diameter were enrolled and randomized to undergo rEBUS-TBB with a GS (GS group) or without a GS (non-GS group) using a 4.0-mm thin bronchoscope, virtual bronchoscopic navigation, and fluoroscopy. The primary endpoint was the diagnostic yield of the histology specimens. RESULTS A total of 605 patients were enrolled; ultimately, data on 596 (300 in the GS group and 296 in the non-GS group) with peripheral pulmonary lesions having a longest median diameter of 19.6 mm were analyzed. The diagnostic yield of histological specimens from the GS group was significantly higher than that from the non-GS group (55.3% versus 46.6%, respectively; p=0.033). Interactions were evident between the diagnostic yields, procedures, lobar locations (upper lobe versus other regions, p=0.003), and lesion texture (solid versus part-solid nodules, p=0.072). CONCLUSIONS The diagnostic yield for small peripheral pulmonary lesions afforded by rEBUS-TBB using a GS was higher than that without a GS.