Design of a prospective, multicenter, global, cohort study of electromagnetic navigation bronchoscopy

BMC Pulmonary Medicine

Study Protocol

Erik E. Folch¹  Sandeep J. Khandhar²  Mark R. Bowling³  Momen M. Wahidi⁴  Thomas R. Gildea⁵  Terence Williams⁶  Eric M. Toloza⁷  Septimiu D. Murgu⁸  Kristin L. Hood⁹ 

[1] Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA;Division of Thoracic Surgery and Interventional Pulmonology, Beth Israel Deaconess Medical Center, Harvard Medical School, 185 Pilgrim Road, Deaconess Building, Suite 201, 02215, Boston, MA, USA;CVTSA/Inova Health System, Fairfax Hospital, Falls Church, VA, USA;Department of Internal Medicine, Division of Pulmonary Critical Care and Sleep Medicine, Brody School of Medicine, East Carolina University, Greenville, NC, USA;Department of Medicine, Duke University School of Medicine, Durham, NC, USA;Department of Pulmonary, Allergy, and Critical Care Medicine and Transplant Center, Cleveland Clinic Foundation, Cleveland, OH, USA;Department of Radiation Oncology, The Ohio State University Wexner Medical Center, Columbus, OH, USA;Department of Thoracic Oncology, Moffitt Cancer Center, Tampa, FL, USA;Interventional Pulmonology Fellowship Program, The University of Chicago Medicine, Chicago, IL, USA;Medtronic, Mansfield, MA, USA;

关键词: Bronchoscopy;    Electromagnetic navigation;    Image-guided biopsy;    Lung cancer;    Lung neoplasms;    Neoplasm staging;    Solitary pulmonary nodule;    superDimension;   

DOI  :  10.1186/s12890-016-0228-y

 received in 2015-12-01, accepted in 2016-04-14,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundElectromagnetic navigation bronchoscopy (ENB) procedures allow physicians to access peripheral lung lesions beyond the reach of conventional bronchoscopy. However, published research is primarily limited to small, single-center studies using previous-generation ENB software. The impact of user experience, patient factors, and lesion/procedural characteristics remains largely unexplored in a large, multicenter study.Methods/DesignNAVIGATE (Clinical Evaluation of superDimension™ Navigation System for Electromagnetic Navigation Bronchoscopy) is a prospective, multicenter, global, cohort study. The study aims to enroll up to 2,500 consecutive subjects presenting for evaluation of lung lesions utilizing the ENB procedure at up to 75 clinical sites in the United States, Europe, and Asia. Subjects will be assessed at baseline, at the time of procedure, and at 1, 12, and 24 months post-procedure. The pre-test probability of malignancy will be determined for peripheral lung nodules. Endpoints include procedure-related adverse events, including pneumothorax, bronchopulmonary hemorrhage, and respiratory failure, as well as quality of life, and subject satisfaction. Diagnostic yield and accuracy, repeat biopsy rate, tissue adequacy for genetic testing, and stage at diagnosis will be reported for biopsy procedures. Complementary technologies, such as fluoroscopy and endobronchial ultrasound, will be explored. Success rates of fiducial marker placement, dye marking, and lymph node biopsies will be captured when applicable. Subgroup analyses based on geography, demographics, investigator experience, and lesion and procedure characteristics are planned.DiscussionStudy enrollment began in April 2015. As of February 19, 2016, 500 subjects had been enrolled at 23 clinical sites with enrollment ongoing. NAVIGATE will be the largest prospective, multicenter clinical study on ENB procedures to date and will provide real-world experience data on the utility of the ENB procedure in a broad range of clinical scenarios.Trial registrationClinicalTrials.gov NCT02410837. Registered 31 March 2015.

【 授权许可】

CC BY   
© Folch et al. 2016