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Randomized Controlled Trial
. 2017 Dec 11;17(1):184.
doi: 10.1186/s12890-017-0531-2.

Virtual bronchoscopic navigation without X-ray fluoroscopy to diagnose peripheral pulmonary lesions: a randomized trial

Fumihiro Asano  1 , Takashi Ishida  2 , Naofumi Shinagawa  3 , Noriaki Sukoh  4 , Masaki Anzai  5 , Kenya Kanazawa  2 , Akifumi Tsuzuku  6 , Satoshi Morita  7
Affiliations
Randomized Controlled Trial

Virtual bronchoscopic navigation without X-ray fluoroscopy to diagnose peripheral pulmonary lesions: a randomized trial

Fumihiro Asano et al. BMC Pulm Med. .

Abstract

Background: Transbronchial biopsy for peripheral pulmonary lesions is generally performed under X-ray fluoroscopy. Virtual bronchoscopic navigation (VBN) is a method in which virtual images of the bronchial route to the lesion are produced based on CT images obtained before VBN, and the bronchoscope is guided using these virtual images, improving the diagnostic yield of peripheral pulmonary lesions. VBN has the possibility of eliminating the need for X-ray fluoroscopy in the bronchoscopic diagnosis of peripheral lesions. To determine whether VBN can be a substitute for X-ray fluoroscopy, a randomized multicenter trial (non-inferiority trial) was performed in VBN and X-ray fluoroscopy (XRF) -assisted groups.

Methods: The non-inferiority margin in the VBN-assisted group compared with the XRF-assisted group was set at 15%. The subjects consisted of 140 patients with peripheral pulmonary lesions with a mean diameter > 3 cm. In the VBN-assisted group, the bronchoscope was guided to the lesion using a VBN system without X-ray fluoroscopy. In the XRF-assisted group, the same bronchoscope was guided to the lesion under X-ray fluoroscopy. Subsequently, in both groups, the lesion was visualized using endobronchial ultrasonography with a guide sheath (EBUS/GS), and biopsy was performed. In this serial procedure, X-ray fluoroscopy was not used in the VBNA group.

Results: The subjects of analysis consisted of 129 patients. The diagnostic yield was 76.9% (50/65) in the VBN-assisted group and 85.9% (55/64) in the XRF-assisted group. The difference in the diagnostic yield between the two groups was -9.0% (95% confidence interval: -22.3% ~ 4.3%). The non-inferiority of the VBN-assisted group could not be confirmed. The rate of visualizing lesions by EBUS was 95.4% (62/65) in the VBN-assisted group and 96.9% (62/64) in the XRF-assisted group, being high in both groups.

Conclusions: On EBUS/GS, a bronchoscope and biopsy instruments may be guided to the lesions using VBN without X-ray fluoroscopy, but X-ray fluoroscopy is necessary to improve the accuracy of sample collection from lesions. During transbronchial biopsy for peripheral pulmonary lesions, VBN cannot be a substitute for X-ray fluoroscopy.

Trial registration: UMIN-CTR (UMIN000001710); registered 16 February 2009.

Keywords: Bronchoscopy; Endobronchial ultrasonography; Guide sheath; Lung cancer; Peripheral pulmonary lesion; Transbronchial biopsy; Virtual bronchoscopic navigation; X-ray fluoroscopy.

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Conflict of interest statement

Ethics approval and consent to participate

The review boards of each participating institution approved all study protocols (Ethics Review Committee of Gifu Prefectural General Medical Center, 2008-14; Research ethics committee of Fukushima medical university, 837; Research ethics committee of Hokkaido University School of Medicine, 008-0115; Ethics Review Committee of National Hospital Organization Hokkaido Cancer Center, 20-7; Institutional Review Board of University of Fukui Hospital, 2009-819) and all patients provided written informed consent to participate according to the Declaration of Helsinki.

Consent for publication

Not Applicable.

Competing interests

Dr. Fumihiro Asano has received speaker fees from Olympus Medical Systems as invited guests to academic medical meetings. All other authors declare that they have no conflict of interest.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
CONSORT flow diagram. VBN, virtual bronchoscopic navigation
See this image and copyright information in PMC

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