The Impact of Biopsy Tool Choice and Rapid On-Site Evaluation on Diagnostic Accuracy for Malignant Lesions in the Prospective: Multicenter NAVIGATE Study. Issue 3 (July 2021)

• Record Type: Journal Article
• Authors: Gildea, Thomas R.; Folch, Erik E.; Khandhar, Sandeep J.; Pritchett, Michael A.; LeMense, Gregory P.; Linden, Philip A.; Arenberg, Douglas A.; Rickman, Otis B.; Mahajan, Amit K.; Singh, Jaspal; Cicenia, Joseph; Mehta, Atul C.; Lin, Haiying; Mattingley, Jennifer S.
• Is Part Of: Journal of bronchology & interventional pulmonology. Volume 28:Issue 3(2021)
• Publication Date: 2021-07
• Subjects: aspiration biopsy -- fine-needle -- bronchoscopy -- image-guided biopsy -- lung neoplasms/diagnosis; Bronchoscopy -- Periodicals; Lungs -- Diseases -- Periodicals; Respiratory Tract Diseases -- Periodicals; Lung Diseases -- surgery -- Periodicals; Diagnostic Techniques, Respiratory System -- Periodicals; Bronchi; Bronchoscopy; Lungs -- Diseases; Periodicals; 616.23
• DOI: 10.1097/LBR.0000000000000740
• Languages: English
• ISSNs: 1944-6586

Abstract

Abstract : Background: The diagnostic yield of electromagnetic navigation bronchoscopy (ENB) is impacted by biopsy tool strategy and rapid on-site evaluation (ROSE) use. This analysis evaluates usage patterns, accuracy, and safety of tool strategy and ROSE in a multicenter study. Methods: NAVIGATE (NCT02410837) evaluates ENB using the superDimension navigation system (versions 6.3 to 7.1). The 1-year analysis included 1215 prospectively enrolled subjects at 29 United States sites. Included herein are 416 subjects who underwent ENB-aided biopsy of a single lung lesion positive for malignancy at 1 year. Use of a restricted number of tools (only biopsy forceps, standard cytology brush, and/or bronchoalveolar lavage) was compared with an extensive multimodal strategy (biopsy forceps, cytology brush, aspirating needle, triple needle cytology brush, needle-tipped cytology brush, core biopsy system, and bronchoalveolar lavage). Results: Of malignant cases, 86.8% (361/416) of true positive diagnoses were obtained using extensive multimodal strategies. ROSE was used in 300/416 cases. The finding of malignancy by ROSE reduced the total number of tools used. A malignant ROSE call was obtained in 71% (212/300), most (88.7%; 188/212) by the first tool used (49.5% with aspirating needle, 20.2% with cytology brush, 17.0% with forceps). True positive rates were highest for the biopsy forceps (86.9%) and aspirating needle (86.6%). Use of extensive tool strategies did not increase the rates of pneumothorax (5.5% restricted, 2.8% extensive) or bronchopulmonary hemorrhage (3.6% restricted, 1.1% extensive). Conclusion: These results suggest that extensive biopsy tool strategies, including the aspirating needle, may provide higher true positive rates for detecting lung cancer without increasing complications.