Virtual bronchoscopic navigation and endobronchial ultrasound with a guide sheath without fluoroscopy for diagnosing peripheral pulmonary lesions with a bronchus leading to or adjacent to the lesion: A randomized non-inferiority trial

doi:10.1111/resp.14405

Randomized Controlled Trial

. 2023 Apr;28(4):389-398.

doi: 10.1111/resp.14405. Epub 2022 Nov 10.

Virtual bronchoscopic navigation and endobronchial ultrasound with a guide sheath without fluoroscopy for diagnosing peripheral pulmonary lesions with a bronchus leading to or adjacent to the lesion: A randomized non-inferiority trial

Xiaoxuan Zheng¹, Changhao Zhong², Fangfang Xie¹, Shiyue Li², Guiqi Wang³, Lei Zhang³, Jiayuan Sun¹

Affiliations

¹ Department of Respiratory Endoscopy and Department of Respiratory and Critical Care Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai Engineering Research Center of Respiratory Endoscopy, Shanghai, China.
² State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.
³ Department of Endoscopy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

PMID: 36356596
DOI: 10.1111/resp.14405

Randomized Controlled Trial

Virtual bronchoscopic navigation and endobronchial ultrasound with a guide sheath without fluoroscopy for diagnosing peripheral pulmonary lesions with a bronchus leading to or adjacent to the lesion: A randomized non-inferiority trial

Xiaoxuan Zheng et al. Respirology. 2023 Apr.

. 2023 Apr;28(4):389-398.

doi: 10.1111/resp.14405. Epub 2022 Nov 10.

Authors

Xiaoxuan Zheng¹, Changhao Zhong², Fangfang Xie¹, Shiyue Li², Guiqi Wang³, Lei Zhang³, Jiayuan Sun¹

Affiliations

¹ Department of Respiratory Endoscopy and Department of Respiratory and Critical Care Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai Engineering Research Center of Respiratory Endoscopy, Shanghai, China.
² State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.
³ Department of Endoscopy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

PMID: 36356596
DOI: 10.1111/resp.14405

Abstract

Background and objective: Transbronchial sampling of peripheral pulmonary lesions (PPLs) is routinely performed under fluoroscopy. However, advanced ancillary techniques have become available, such as virtual bronchoscopic navigation (VBN) and radial endobronchial ultrasound with a guide sheath (rEBUS-GS). This study was performed to determine whether the diagnostic utility of VBN and rEBUS with a GS is similar with or without fluoroscopy.

Methods: This multicenter non-inferiority trial randomized patients to a VBN-rEBUS-GS with or without fluoroscopy group at three centres. The primary endpoint was the diagnostic yield. The secondary endpoints were the time for rEBUS, GS, and the total operation. Complications were also recorded.

Results: Four hundred and ninety-six subjects were assessed and 426 subjects were included in the analysis (212 in non-fluoroscopy-guided-group and 214 in fluoroscopy-guided-group). The diagnostic yield in the non-fluoroscopy-guided-group (84.0%) was not inferior to that in the fluoroscopy-guided-group (84.6%), with a diagnostic difference of -0.6% (95% CI: -6.4%, 5.2%). Multivariable analysis confirmed that bronchus sign and lesion nature were valuable diagnostic predictors in non-fluoroscopy-guided-group. The non-fluoroscopy-guided-group had shorter rEBUS, GS, and total operation time. No severe complications occurred in either group.

Conclusion: Transbronchial diagnosis of PPLs suspicious of malignancy and presence of a bronchus leading to or adjacent to lesions using VBN-rEBUS-GS without fluoroscopy is a safe and effective method that is non-inferior to VBN-rEBUS-GS with fluoroscopy. Bronchus leading to lesions and malignant nature are associated with high diagnostic yield in VBN-rEBUS-GS without fluoroscopy for the diagnosis of PPLs.

Keywords: endobronchial ultrasound; fluoroscopy; peripheral pulmonary lesions; transbronchial lung biopsy; virtual bronchoscopic navigation.

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References

REFERENCES

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1. Mizugaki H, Shinagawa N, Kanegae K, Yamada N, Asahina H, Kikuchi E, et al. Combining transbronchial biopsy using endobronchial ultrasonography with a guide sheath and positron emission tomography for the diagnosis of small peripheral pulmonary lesions. Lung Cancer. 2010;68(2):211-5.
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[1] Schreiber G, McCrory DC. Performance characteristics of different modalities for diagnosis of suspected lung cancer: summary of published evidence. Chest. 2003;123(Suppl 1):115S-28S.

[2] Schreiber G, McCrory DC. Performance characteristics of different modalities for diagnosis of suspected lung cancer: summary of published evidence. Chest. 2003;123(Suppl 1):115S-28S.

[3] Mizugaki H, Shinagawa N, Kanegae K, Yamada N, Asahina H, Kikuchi E, et al. Combining transbronchial biopsy using endobronchial ultrasonography with a guide sheath and positron emission tomography for the diagnosis of small peripheral pulmonary lesions. Lung Cancer. 2010;68(2):211-5.

[4] Mizugaki H, Shinagawa N, Kanegae K, Yamada N, Asahina H, Kikuchi E, et al. Combining transbronchial biopsy using endobronchial ultrasonography with a guide sheath and positron emission tomography for the diagnosis of small peripheral pulmonary lesions. Lung Cancer. 2010;68(2):211-5.

[5] Rivera MP, Mehta AC, Wahidi MM. Establishing the diagnosis of lung cancer: diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013;143(5 Suppl):e142S-65S.

[6] Rivera MP, Mehta AC, Wahidi MM. Establishing the diagnosis of lung cancer: diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013;143(5 Suppl):e142S-65S.

[7] Baaklini WA, Reinoso MA, Gorin AB, Sharafkaneh A, Manian P. Diagnostic yield of fiberoptic bronchoscopy in evaluating solitary pulmonary nodules. Chest. 2000;117(4):1049-54.

[8] Baaklini WA, Reinoso MA, Gorin AB, Sharafkaneh A, Manian P. Diagnostic yield of fiberoptic bronchoscopy in evaluating solitary pulmonary nodules. Chest. 2000;117(4):1049-54.

[9] Herth FJ, Eberhardt R, Becker HD, Ernst A. Endobronchial ultrasound-guided transbronchial lung biopsy in fluoroscopically invisible solitary pulmonary nodules: a prospective trial. Chest. 2006;129(1):147-50.

[10] Herth FJ, Eberhardt R, Becker HD, Ernst A. Endobronchial ultrasound-guided transbronchial lung biopsy in fluoroscopically invisible solitary pulmonary nodules: a prospective trial. Chest. 2006;129(1):147-50.

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Virtual bronchoscopic navigation and endobronchial ultrasound with a guide sheath without fluoroscopy for diagnosing peripheral pulmonary lesions with a bronchus leading to or adjacent to the lesion: A randomized non-inferiority trial

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Virtual bronchoscopic navigation and endobronchial ultrasound with a guide sheath without fluoroscopy for diagnosing peripheral pulmonary lesions with a bronchus leading to or adjacent to the lesion: A randomized non-inferiority trial

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