Masahide Oki1, Hideo Saka1, Masahiko Ando2, Fumihiro Asano3, Noriaki Kurimoto4, Katsuhiko Morita5, Chiyoe Kitagawa1, Yoshihito Kogure1, Teruomi Miyazawa6. 1. 1 Department of Respiratory Medicine, Nagoya Medical Center, Nagoya, Japan. 2. 2 Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, Nagoya, Japan. 3. 3 Department of Pulmonary Medicine, Gifu Prefectural General Medical Center, Gifu, Japan. 4. 4 Department of Chest Surgery and. 5. 5 Department of Surgery, Iwakuni Minami Hospital, Iwakuni, Japan. 6. 6 Department of Pulmonary and Infectious Diseases, St. Marianna University School of Medicine, Kawasaki, Japan; and.
Abstract
RATIONALE: The combination of an ultrathin bronchoscope, navigational technology, and endobronchial ultrasound (EBUS) seems to combine the best of mutual abilities for evaluating peripheral pulmonary lesions, but ultrathin bronchoscopes that allow the use of EBUS have not been developed so far. OBJECTIVES: To compare the diagnostic yield of transbronchial biopsy under EBUS, fluoroscopy, and virtual bronchoscopic navigation guidance using a novel ultrathin bronchoscope with that using a thin bronchoscope with a guide sheath for peripheral pulmonary lesions. METHODS: In four centers, patients with suspected peripheral pulmonary lesions less than or equal to 30 mm in the longest diameter were included and randomized to undergo transbronchial biopsy with EBUS, fluoroscopy, and virtual bronchoscopic navigation guidance using a 3.0-mm ultrathin bronchoscope (UTB group) or a 4.0-mm thin bronchoscope with a guide sheath (TB-GS group). MEASUREMENTS AND MAIN RESULTS: A total of 310 patients were enrolled and randomized, among whom 305 patients (150, UTB group; 155, TB-GS group) were analyzed. The ultrathin bronchoscope could reach more distal bronchi than the thin bronchoscope (median fifth- vs. fourth-generation bronchi; P < 0.001). Diagnostic histologic specimens were obtained in 74% (42% for benign and 81% for malignant lesions) of the UTB group and 59% (36% for benign and 70% for malignant lesions) of the TB-GS group (P = 0.044, Mantel-Haenszel test). Complications including pneumothorax, bleeding, chest pain, and pneumonia occurred in 3% and 5% in the respective groups. CONCLUSIONS: The diagnostic yield of the UTB method is higher than that of the TB-GS method. Clinical trial registered with www.umin.ac.jp/ctr/ (UMIN 000003177).
RCT Entities:
RATIONALE: The combination of an ultrathin bronchoscope, navigational technology, and endobronchial ultrasound (EBUS) seems to combine the best of mutual abilities for evaluating peripheral pulmonary lesions, but ultrathin bronchoscopes that allow the use of EBUS have not been developed so far. OBJECTIVES: To compare the diagnostic yield of transbronchial biopsy under EBUS, fluoroscopy, and virtual bronchoscopic navigation guidance using a novel ultrathin bronchoscope with that using a thin bronchoscope with a guide sheath for peripheral pulmonary lesions. METHODS: In four centers, patients with suspected peripheral pulmonary lesions less than or equal to 30 mm in the longest diameter were included and randomized to undergo transbronchial biopsy with EBUS, fluoroscopy, and virtual bronchoscopic navigation guidance using a 3.0-mm ultrathin bronchoscope (UTB group) or a 4.0-mm thin bronchoscope with a guide sheath (TB-GS group). MEASUREMENTS AND MAIN RESULTS: A total of 310 patients were enrolled and randomized, among whom 305 patients (150, UTB group; 155, TB-GS group) were analyzed. The ultrathin bronchoscope could reach more distal bronchi than the thin bronchoscope (median fifth- vs. fourth-generation bronchi; P < 0.001). Diagnostic histologic specimens were obtained in 74% (42% for benign and 81% for malignant lesions) of the UTB group and 59% (36% for benign and 70% for malignant lesions) of the TB-GS group (P = 0.044, Mantel-Haenszel test). Complications including pneumothorax, bleeding, chest pain, and pneumonia occurred in 3% and 5% in the respective groups. CONCLUSIONS: The diagnostic yield of the UTB method is higher than that of the TB-GS method. Clinical trial registered with www.umin.ac.jp/ctr/ (UMIN 000003177).
Authors: Nichole T Tanner; Lonny Yarmus; Alexander Chen; Jessica Wang Memoli; Hiren J Mehta; Nicholas J Pastis; Hans Lee; Michael A Jantz; Paul J Nietert; Gerard A Silvestri Journal: Chest Date: 2018-08-23 Impact factor: 9.410