Liyan Bo1, Congcong Li2, Lei Pan1, Hongwu Wang3, Shiyue Li4, Qiang Li5, Chong Bai5, Yiming Zeng6, Yandong Nan1, Yan Wang1, Haidong Huang5, Rui Zhou7, Hongmei Zhou8, Wen Liu8, Jiayuan Sun9, Zhiguang Liu10, Faguang Jin11. 1. Department of Respiratory and Critical Care Medicine, Tangdu Hospital, Air Force Medical University, Xi'an, PR China. 2. Department of Respiratory and Critical Care Medicine, General Hospital of Northern Theater, Shenyang, PR China. 3. Department of Respiratory Medicine, Meitan General Hospital, Beijing, PR China. 4. Gungzhou Institute of Respiratory Health, State Key Laboratory of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, PR China. 5. Department of Respiratory Medicine, Changhai Hospital, Second Military Medical University, Shanghai, 200080, PR China. 6. Department of Respiratory Pulmonary and Critical Care Medicine, The Second Hospital of Fujian Medical University, Quanzhou, Fujian Province, PR China. 7. Department of Respiratory Medicine, The Second Xiangya Hospital, Central South University, Changsha, Hunan, 410011, PR China. 8. Department of Respiratory Medicine, The Second Hospital of Gansu Province, Lanzhou, Gansu, PR China. 9. Department of Respiratory Medicine, Shanghai Pulmonary Hospital, Shanghai, 200080, PR China. 10. Department of Respiratory Medicine, Hunan People's Hospital, Changsha, Hunan, PR China. 11. Department of Respiratory and Critical Care Medicine, Tangdu Hospital, Air Force Medical University, Xi'an, PR China. Electronic address: jinfag@fmmu.edu.cn.
Abstract
BACKGROUND: The rate of detection of pulmonary nodules on computed radiography (CR) is approximately 0.09-0.2%, so rapid identification of the nature of solitary pulmonary nodules (SPNs) with a likelihood of malignancy is a critical challenge in the early diagnosis of lung cancer. OBJECTIVE: We conducted this study to compare the diagnostic yield and safety of endobronchial ultrasonography with a guide sheath (EBUS-GS), and the combination of EBUS-GS and virtual bronchoscopic navigation (VBN). METHODS: This was a prospective, multicenter, multi-arm, randomized controlled trial involving a total of 1010 subjects. All the patients recruited underwent a chest CT scan which found SPNs that needed to be diagnosed. The subjects were randomly divided into one of three groups: a traditional, non-guided, bronchoscopy biopsy group (NGB group), an EBUS-GS guided bronchoscopy biopsy group (EBUS group), and a guided bronchoscopy biopsy group that combined EBUS-GS with VBN (combined group). The primary endpoint was to investigate the differences between the diagnostic yields of the three groups. RESULTS: There was no significant difference in the diagnostic yield between the EBUS group (72.3%) and the combined group (74.3%), but the diagnostic yield for the NGB group was 41.2%. The time required to reach biopsy position was significantly less in the combined group (7.96 ± 1.18 min in the combined group versus 11.92 ± 5.37 min in the EBUS group, p < 0.05). However, the bronchoscope operation time was the same in the EBUS-GS and combined groups. The diagnostic yield for peripheral pulmonary lesions (PPLs) >20 mm in diameter was significantly higher than for those <20 mm in diameter. CONCLUSION: The results of our study suggest that guided bronchoscopy could increase the diagnostic yield in the context of peripheral lesions. There was no significant difference in the diagnostic yield between the EBUS and combined groups, but use of EBUS-GS with VBN could significantly shorten the bronchoscope arrival time.
RCT Entities:
BACKGROUND: The rate of detection of pulmonary nodules on computed radiography (CR) is approximately 0.09-0.2%, so rapid identification of the nature of solitary pulmonary nodules (SPNs) with a likelihood of malignancy is a critical challenge in the early diagnosis of lung cancer. OBJECTIVE: We conducted this study to compare the diagnostic yield and safety of endobronchial ultrasonography with a guide sheath (EBUS-GS), and the combination of EBUS-GS and virtual bronchoscopic navigation (VBN). METHODS: This was a prospective, multicenter, multi-arm, randomized controlled trial involving a total of 1010 subjects. All the patients recruited underwent a chest CT scan which found SPNs that needed to be diagnosed. The subjects were randomly divided into one of three groups: a traditional, non-guided, bronchoscopy biopsy group (NGB group), an EBUS-GS guided bronchoscopy biopsy group (EBUS group), and a guided bronchoscopy biopsy group that combined EBUS-GS with VBN (combined group). The primary endpoint was to investigate the differences between the diagnostic yields of the three groups. RESULTS: There was no significant difference in the diagnostic yield between the EBUS group (72.3%) and the combined group (74.3%), but the diagnostic yield for the NGB group was 41.2%. The time required to reach biopsy position was significantly less in the combined group (7.96 ± 1.18 min in the combined group versus 11.92 ± 5.37 min in the EBUS group, p < 0.05). However, the bronchoscope operation time was the same in the EBUS-GS and combined groups. The diagnostic yield for peripheral pulmonary lesions (PPLs) >20 mm in diameter was significantly higher than for those <20 mm in diameter. CONCLUSION: The results of our study suggest that guided bronchoscopy could increase the diagnostic yield in the context of peripheral lesions. There was no significant difference in the diagnostic yield between the EBUS and combined groups, but use of EBUS-GS with VBN could significantly shorten the bronchoscope arrival time.