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Randomized Controlled Trial
. 2011 Dec;66(12):1072-7.
doi: 10.1136/thx.2010.145490. Epub 2011 Jul 11.

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

Takashi Ishida  1 , Fumihiro Asano, Koichi Yamazaki, Naofumi Shinagawa, Satoshi Oizumi, Hiroshi Moriya, Mitsuru Munakata, Masaharu Nishimura; Virtual Navigation in Japan Trial Group
Collaborators, Affiliations
Randomized Controlled Trial

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

Takashi Ishida et al. Thorax. 2011 Dec.

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.

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Conflict of interest statement

Competing interests: FA, HM, KY, TI and Olympus Medical Systems Corporation co-developed the VBN system. FA, HM, KY and TI legally transferred all patent rights to Olympus Corporation without compensation. TI, FA and NS have received speaker fees of less than three hundred thousand yen (∼US$3500) per year each from the Olympus Corporation as invited guests to academic medical meetings. All other authors declare that they have no conflict of interest.

Figures

Figure 1
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
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.
See this image and copyright information in PMC

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