Virtual bronchoscopic navigation combined with endobronchial ultrasound to diagnose small peripheral pulmonary lesions: a randomised trial

Abstract

Background: Bronchoscopy using endobronchial ultrasound (EBUS) can help to diagnose small peripheral pulmonary lesions. However, although biopsy sites can be confirmed, a bronchoscope cannot be guided in EBUS. Virtual bronchoscopic navigation (VBN) can guide a bronchoscope with virtual images, but its value has not been confirmed.

Methods: This prospective multicentre study examines the value of VBN-assisted EBUS for diagnosing small peripheral pulmonary lesions. 199 patients with small peripheral pulmonary lesions (diameter ≤30 mm) were randomly assigned to VBN-assisted (VBNA) or non-VBN-assisted (NVBNA) groups. A bronchoscope was introduced into the target bronchus of the VBNA group using the VBN system. Sites of specimen sampling were verified using EBUS with a guide sheath under fluoroscopy.

Results: The diagnostic yield was higher for the VBNA than for the NVBNA group (80.4% vs 67.0%; p = 0.032). The duration of the examination and time elapsed until the start of sample collection were reduced in the VBNA compared with the NVBNA group (median (range), 24.0 (8.7-47.0) vs 26.2 (11.6-58.6) min, p = 0.016) and 8.1 (2.8-39.2) vs 9.8 (2.3-42.3) min, p = 0.045, respectively). The only adverse event was mild pneumothorax in a patient from the NVBNA group.

Conclusions: The diagnostic yield for small peripheral pulmonary lesions is increased when VBN is combined with EBUS. Clinical trial number UMIN000000569.

Figure 1

Virtual bronchoscopic navigation. An assistant physician controls virtual bronchoscopic images of the path leading to a peripheral lesion and a bronchoscopist inserts an endoscope as instructed.

Figure 2

CONSORT flow diagram. *All allocated patients were included in the intention-to-treat population. †Diagnoses established without operating virtual bronchoscopic navigation (VBN). ‡The bronchoscopic procedure was performed according to protocol. §Final diagnosis of this patient was not established; however, this patient was included in the per-protocol analysis.