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

Takashi Ishida, Fumihiro Asano, Koichi Yamazaki, Naofumi Shinagawa, Satoshi Oizumi, Hiroshi Moriya, Mitsuru Munakata, Masaharu Nishimura, Virtual Navigation in Japan Trial Group, Koichi Yamazaki, Naofumi Shinagawa, Satoshi Oizumi, Eiki Kikuchi, Hajime Asahina, Noriyuki Yamada, Hiroshi Yokouchi, Chie Yoshida, Masaharu Nishimura, Yuya Onodera, Kazuo Miyasaka, Yoshihiko Matsuno, Akifumi Tsuzuku, Masaki Anzai, Atsunori Masuda, Hiroshi Moriya, Takashi Ishida, Motoko Tachihara, Kenya Kanazawa, Aya Sugawara, Kana Watanabe, Kumi Uekita, Kengo Oshima, Satoko Sekine, Mitsuru Munakata, Takashi Ishida, Fumihiro Asano, Koichi Yamazaki, Naofumi Shinagawa, Satoshi Oizumi, Hiroshi Moriya, Mitsuru Munakata, Masaharu Nishimura, Virtual Navigation in Japan Trial Group, Koichi Yamazaki, Naofumi Shinagawa, Satoshi Oizumi, Eiki Kikuchi, Hajime Asahina, Noriyuki Yamada, Hiroshi Yokouchi, Chie Yoshida, Masaharu Nishimura, Yuya Onodera, Kazuo Miyasaka, Yoshihiko Matsuno, Akifumi Tsuzuku, Masaki Anzai, Atsunori Masuda, Hiroshi Moriya, Takashi Ishida, Motoko Tachihara, Kenya Kanazawa, Aya Sugawara, Kana Watanabe, Kumi Uekita, Kengo Oshima, Satoko Sekine, Mitsuru Munakata

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.

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.

References

    1. Sant M, Allemani C, Santaquilani M, et al. EUROCARE-4. Survival of cancer patients diagnosed in 1995–1999. Results and commentary. Eur J Cancer 2009;45:931–91
    1. Jemal A, Siegel R, Ward E, et al. Cancer statistics, 2009. CA Cancer J Clin 2009;59:225–49
    1. Matsuda T, Marugame T, Kamo K, et al. Cancer incidence and incidence rates in Japan in 2002: based on data from 11 population-based cancer registries. Jpn J Clin Oncol 2008;38:641–8
    1. Jacobs PC, Mali WP, Grobbee DE, et al. Prevalence of incidental findings in computed tomographic screening of the chest: a systematic review. J Comput Assist Tomogr 2008;32:214–21
    1. Baaklini WA, Reinoso MA, Gorin AB, et al. Diagnostic yield of fiberoptic bronchoscopy in evaluating solitary pulmonary nodules. Chest 2000;117:1049–54
    1. Schreiber G, McCrory DC. Performance characteristics of different modalities for diagnosis of suspected lung cancer: summary of published evidence. Chest 2003;123:115S–28S
    1. Yung RC. Tissue diagnosis of suspected lung cancer: selecting between bronchoscopy, transthoracic needle aspiration, and resectional biopsy. Respir Care Clin N Am 2003;9:51–76
    1. Rivera MP, Mehta AC. Initial diagnosis of lung cancer: ACCP evidence-based clinical practice guidelines (2nd edition). Chest 2007;132(3 Suppl):131S–48S
    1. Manhire A, Charig M, Clelland C, et al. Guidelines for radiologically guided lung biopsy. Thorax 2003;58:920–36
    1. Paone G, Nicastri E, Lucantoni G, et al. Endobronchial ultrasound-driven biopsy in the diagnosis of peripheral lung lesions. Chest 2005;128:3551–7
    1. Herth FJ, Ernst A, Becker HD. Endobronchial ultrasound-guided transbronchial lung biopsy in solitary pulmonary nodules and peripheral lesions. Eur Respir J 2002;20:972–4
    1. Kurimoto N, Miyazawa T, Okimasa S, et al. Endobronchial ultrasonography using a guide sheath increases the ability to diagnose peripheral pulmonary lesions endoscopically. Chest 2004;126:959–65
    1. Kikuchi E, Yamazaki K, Sukoh N, et al. Endobronchial ultrasonography with guide-sheath for peripheral pulmonary lesions. Eur Respir J 2004;24:533–7
    1. Schwarz Y, Mehta AC, Ernst A, et al. Electromagnetic navigation during flexible bronchoscopy. Respiration 2003;70:516–22
    1. Becker H, Herth F, Ernst A. Bronchoscopic biopsy of peripheral lung lesions under electromanetic guidance: a pilot study. J Bronchol 2005;12:9–13
    1. Schwarz Y, Greif J, Becker HD, et al. Real-time electromagnetic navigation bronchoscopy to peripheral lung lesions using overlaid CT images: the first human study. Chest 2006;129:988–94
    1. Gildea TR, Mazzone PJ, Karnak D, et al. Electromagnetic navigation diagnostic bronchoscopy: a prospective study. Am J Respir Crit Care Med 2006;174:982–9
    1. Eberhardt R, Anantham D, Ernst A, et al. Multimodality bronchoscopic diagnosis of peripheral lung lesions: a randomized controlled trial. Am J Respir Crit Care Med 2007;176:36–41
    1. Asano F, Matsuno Y, Matsushita T, et al. Transbronchial diagnosis of a pulmonary peripheral small lesion using an ultrathin bronchoscope with virtual bronchoscopic navigation. J Bronchol 2002;9:108–11
    1. Asano F, Matsuno Y, Shinagawa N, et al. A virtual bronchoscopic navigation system for pulmonary peripheral lesions. Chest 2006;130:559–66
    1. Asano F, Matsuno Y, Tsuzuku A, et al. Diagnosis of peripheral pulmonary lesions using a bronchoscope insertion guidance system combined with endobronchial ultrasonography with a guide sheath. Lung Cancer 2008;60:366–73
    1. Asahina H, Yamazaki K, Onodera Y, et al. Transbronchial biopsy using endobronchial ultrasonography with a guide sheath and virtual bronchoscopic navigation. Chest 2005;128:1761–5
    1. Tachihara M, Ishida T, Kanazawa K, et al. A virtual bronchoscopic navigation system under X-ray fluoroscopy for transbronchial diagnosis of small peripheral pulmonary lesions. Lung Cancer 2007;57:322–7
    1. Eberhardt R, Kahn N, Gompelmann D, et al. LungPoint—a new approach to peripheral lesions. J Thorac Oncol 2010;5:1559–63
    1. Laurent F, Latrabe V, Vergier B, et al. CT-guided transthoracic needle biopsy of pulmonary nodules smaller than 20 mm: results with an automated 20-gauge coaxial cutting needle. Clin Radiol 2000;55:281–7
    1. Ohno Y, Hatabu H, Takenaka D, et al. CT-guided transthoracic needle aspiration biopsy of small (< or = 20 mm) solitary pulmonary nodules. AJR Am J Roentgenol 2003;180:1665–9
    1. Cox JE, Chiles C, McManus CM, et al. Transthoracic needle aspiration biopsy: variables that affect risk of pneumothorax. Radiology 1999;212:165–8
    1. Ibukuro K, Tanaka R, Takeguchi T, et al. Air embolism and needle track implantation complicating CT-guided percutaneous thoracic biopsy: single-institution experience. AJR Am J Roentgenol 2009;193:W430–6
    1. Gasparini S, Ferretti M, Secchi EB, et al. Integration of transbronchial and percutaneous approach in the diagnosis of peripheral pulmonary nodules or masses. Experience with 1,027 consecutive cases. Chest 1995;108:131–7
    1. Niwa H, Tanahashi M, Kondo T, et al. Bronchoscopy in Japan: a survey by the Japan Society for Respiratory Endoscopy in 2006. Respirology 2009;14:282–9
    1. Steinfort DP, Einsiedel P, Irving LB. Radiation dose to patients and clinicians during fluoroscopically-guided biopsy of peripheral pulmonary lesions. Respir Care 2010;55:1469–74
    1. Neumann K, Winterer J, Kimmig M, et al. Real-time interactive virtual endoscopy of the tracheo-bronchial system: influence of CT imaging protocols and observer ability. Eur J Radiol 2000;33:50–4
    1. Deguchi D, Akiyama K, Mori K, et al. A method for bronchoscope tracking by combining a position sensor and image registration. Comput Aided Surg 2006;11:109–17
    1. Merritt SA, Gibbs JD, Yu KC, et al. Image-guided bronchoscopy for peripheral lung lesions: a phantom study. Chest 2008;134:1017–26
    1. Shinagawa N, Yamazaki K, Onodera Y, et al. CT-guided transbronchial biopsy using an ultrathin bronchoscope with virtual bronchoscopic navigation. Chest 2004;125:1138–43

Source: PubMed

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

3
Předplatit