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

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 diagnosis rate of peripheral pulmonary lesions. VBN has the possibility of eliminating the need for X-ray fluoroscopic guidance for bronchoscopy. Aims and objectives To determine whether VBN can be a substitute for X-ray fluoroscopy, a randomized multicenter trial (non-inferiority trial) was performed in VBN and control groups. The non-inferiority margin in the VBN group compared with the control group was set at 15%. The subjects consisted of 140 patients with peripheral pulmonary lesions with a mean diameter > 3 cm. Methods In the VBN group, the bronchoscopewas guided to the lesion using a navigation system (Bf-NAVI; Cybernet Systems, Tokyo). In the control 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, and biopsy was performed. Results The subjects of analysis consisted of 129 patients. The diagnosis rate was 76.9% (50/65) in the VBN group and 85.9% (55/64) in the control group. The difference in the diagnosis rate between the two groups was -9.0% (95% confidence interval: -22.3% - 4.3%). The non-inferiority of the VBN group could not be confirmed. Conclusion During transbronchial biopsy for peripheral pulmonary lesions, VBN cannot be a substitute for X-ray fluoroscopy.