دورية أكاديمية
A Multicenter, Single-Arm, Prospective Trial Assessing the Diagnostic Yield of Electromagnetic Bronchoscopic and Transthoracic Navigation for Peripheral Pulmonary Nodules.
| العنوان: | A Multicenter, Single-Arm, Prospective Trial Assessing the Diagnostic Yield of Electromagnetic Bronchoscopic and Transthoracic Navigation for Peripheral Pulmonary Nodules. |
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| المؤلفون: | Thiboutot J; Division of Pulmonary and Critical Care Medicine and., Pastis NJ; Division of Pulmonary and Critical Care Medicine, Ohio State University, Columbus, Ohio., Akulian J; Division of Pulmonary and Critical Care Medicine, University of North Carolina, Chapel Hill, North Carolina., Silvestri GA; Division of Pulmonary and Critical Care Medicine, Medical University of South Carolina, Charleston, South Carolina., Chen A; Division of Pulmonary and Critical Care Medicine, Washington University in St. Louis, St. Louis, Missouri., Wahidi MM; Division of Pulmonary and Critical Care Medicine, Northwestern University, Feinberg School of Medicine, Chicago, Illinois., Gilbert CR; Division of Pulmonary and Critical Care Medicine, Medical University of South Carolina, Charleston, South Carolina., Lin CT; Department of Radiology, Johns Hopkins University, Baltimore, Maryland., Los J; Division of Pulmonary and Critical Care Medicine and., Flenaugh E; Division of Pulmonary and Critical Care Medicine, Morehouse School of Medicine, Atlanta, Georgia., Semaan R; Division of Pulmonary, Allergy, and Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania., Burks AC; Division of Pulmonary and Critical Care Medicine, University of North Carolina, Chapel Hill, North Carolina., Sathyanarayan P; Division of Pulmonary and Critical Care Medicine and., Wu S; Division of Pulmonary and Critical Care Medicine and., Feller-Kopman D; Division of Pulmonary and Critical Care Medicine, Dartmouth College, Hanover, New Hampshire., Cheng GZ; Division of Pulmonary and Critical and Sleep Medicine, University of California, San Diego, California., Alalawi R; Division of Pulmonary and Critical Care Medicine, University of Arizona, Tucson, Arizona., Rahman NM; Oxford Centre for Respiratory Medicine, Oxford University Hospitals, Oxford, United Kingdom; and., Maldonado F; Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee., Lee HJ; Division of Pulmonary and Critical Care Medicine and., Yarmus L; Division of Pulmonary and Critical Care Medicine and. |
| المصدر: | American journal of respiratory and critical care medicine [Am J Respir Crit Care Med] 2023 Oct 15; Vol. 208 (8), pp. 837-845. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: American Thoracic Society Country of Publication: United States NLM ID: 9421642 Publication Model: Print Cited Medium: Internet ISSN: 1535-4970 (Electronic) Linking ISSN: 1073449X NLM ISO Abbreviation: Am J Respir Crit Care Med Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2000- : New York, NY : American Thoracic Society Original Publication: New York, NY : American Lung Association, c1994- |
| مستخلص: | Rationale: Strict adherence to procedural protocols and diagnostic definitions is critical to understand the efficacy of new technologies. Electromagnetic navigational bronchoscopy (ENB) for lung nodule biopsy has been used for decades without a solid understanding of its efficacy, but offers the opportunity for simultaneous tissue acquisition via electromagnetic navigational transthoracic biopsy (EMN-TTNA) and staging via endobronchial ultrasound (EBUS). Objective: To evaluate the diagnostic yield of EBUS, ENB, and EMN-TTNA during a single procedure using a strict a priori definition of diagnostic yield with central pathology adjudication. Methods: A prospective, single-arm trial was conducted at eight centers enrolling participants with pulmonary nodules (<3 cm; without computed tomography [CT]- and/or positron emission tomography-positive mediastinal lymph nodes) who underwent a staged procedure with same-day CT, EBUS, ENB, and EMN-TTNA. The procedure was staged such that, when a diagnosis had been achieved via rapid on-site pathologic evaluation, the procedure was ended and subsequent biopsy modalities were not attempted. A study finding was diagnostic if an independent pathology core laboratory confirmed malignancy or a definitive benign finding. The primary endpoint was the diagnostic yield of the combination of CT, EBUS, ENB, and EMN-TTNA. Measurements and Main Results: A total of 160 participants at 8 centers with a mean nodule size of 18 ± 6 mm were enrolled. The diagnostic yield of the combined procedure was 59% (94 of 160; 95% confidence interval [CI], 51-66%). Nodule regression was found on same-day CT in 2.5% of cases (4 of 160; 95% CI, 0.69-6.3%), and EBUS confirmed malignancy in 7.1% of cases (11 of 156; 95% CI, 3.6-12%). The yield of ENB alone was 49% (74 of 150; 95% CI, 41-58%), that of EMN-TTNA alone was 27% (8 of 30; 95% CI, 12-46%), and that of ENB plus EMN-TTNA was 53% (79 of 150; 95% CI, 44-61%). Complications included a pneumothorax rate of 10% and a 2% bleeding rate. When EMN-TTNA was performed, the pneumothorax rate was 30%. Conclusions: The diagnostic yield for ENB is 49%, which increases to 59% with the addition of same-day CT, EBUS, and EMN-TTNA, lower than in prior reports in the literature. The high complication rate and low diagnostic yield of EMN-TTNA does not support its routine use. Clinical trial registered with www.clinicaltrials.gov (NCT03338049). |
| التعليقات: | Comment in: Am J Respir Crit Care Med. 2023 Oct 15;208(8):827-828. (PMID: 37699144) |
| معلومات مُعتمدة: | United States Veran Inc. |
| فهرسة مساهمة: | Keywords: bronchoscopy; electromagnetic navigation; pulmonary nodules |
| سلسلة جزيئية: | ClinicalTrials.gov NCT03338049 |
| تواريخ الأحداث: | Date Created: 20230815 Latest Revision: 20231013 |
| رمز التحديث: | 20231215 |
| DOI: | 10.1164/rccm.202301-0099OC |
| PMID: | 37582154 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1535-4970 |
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| DOI: | 10.1164/rccm.202301-0099OC |