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

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 À0.6% (95% CI: À6.4%, 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.

Radial endobronchial ultrasound - guided bronchoscopy for the diagnosis of peripheral pulmonary lesions: A systematic review and meta-analysis of prospective trials

“…With regard to probe location, it plays a significant role for improving the diagnostic yield. Similar to the results of previously published studies [ 7 , 10 , 12 , [14] , [15] , [16] , 21 , 25 , 27 , 28 , 34 , 49 , 50 , 54 ], in the current meta-analysis, the within position provided the highest diagnostic yield of 82.6 %, followed by the adjacent position 56.8 % and the outside position 17.3 %. The inferior diagnostic yield for the latter two conditions may be because r-EBUS-guided transbronchial biopsy only performs in one plane, resulting in the possibility of PPLs with adjacent and eccentric images being missed [ 74 ].…”

“…Our study indicated that the diagnostic yield of PPLs with a bronchus sign was as high as 74.9 %, significantly higher than PPLs (55.3 %) without a bronchus sign. We note that this is aligned with prior reports [ 10 , 14 , 23 , 24 , 31 , 43 , 54 ]. With regard to probe location, it plays a significant role for improving the diagnostic yield.…”

“…Among these bronchoscopic navigation techniques, r-EBUS, as a common and powerful tool, has been recommended for the diagnosis of PPLs by the American College of Chest Physicians and European Society for Medical Oncology [ 17 , 18 ]. r-EBUS for the diagnosis of PPLs was first reported by Herth et al [ 19 ] in 2002, with a wide range of reported diagnostic yield between 50.0 % and 97.6 %, and complication rates between 0 % and 18.4 % [ [7] , [8] , [9] , [10] , [11] , [12] , [13] , [14] , [15] , [16] , [17] , [18] , [19] , [20] , [21] , [22] , [23] , [24] , [25] , [26] , [27] , [28] , [29] , [30] , [31] , [32] , [33] , [34] , [35] , [36] , [37] , [38] , [39] , [40] , [41] , [42] , [43] , [44] , [45] , [46] , [47] , [48] , [49] , [50] , [51] , [52] , [53] , [54] ]. Accurate estimates of diagnostic yield and complication rates of r-EBUS are critical for clinicians in the management of PPLs.…”

Development of the Korean Association for Lung Cancer Clinical Practice Guidelines: Recommendations on Radial Probe Endobronchial Ultrasound for Diagnosing Lung Cancer - An Updated Meta-Analysis

“…Of these, 75 articles were excluded according to the exclusion criteria, and one study missed in the database search was added [ 22 ]. Therefore, 41 studies formed the basis of our systematic review [ 22 - 62 ].…”

5G-Based Remote Virtual Bronchoscopic Navigation-Guided Transbronchial Lung Biopsy for Diagnosis of Lung Cancer: Description of 2 Cases

“…Currently, bronchoscopic navigation combined with ultrasound-guided TBLB remains the primary and appropriate means for the accurate diagnosis of PPL [5]. Effective sharing of such navigation techniques and experience may be valuable to improve the diagnosis rate of PPL in remote areas, which can contribute to early diagnosis.…”