Navigational Bronchoscopy or Transthoracic Needle Biopsy for Lung Nodules

Author(s): Robert J. Lentz, M.D.1,2,3; Katherine Frederick-Dyer, M.D.4; Virginia B. Planz, M.D.4; Tatsuki Koyama, Ph.D.5; Matthew C. Aboudara, M.D.6; Sameer K. Avasarala, M.D.7; Jonathan D. Casey, M.D.1,8; George Z. Cheng, M.D., Ph.D.9; Pierre-François D’Haese, Ph.D.10; Jennifer D. Duke, M.D.1,2; Eric L. Grogan, M.D., M.P.H.2,11; Todd C. Hoopman, M.D.12; Joyce Johnson, M.D.13; James M. Katsis, M.D.14; Jonathan S. Kurman, M.D.15; See-Wei Low, M.D.16; Kamran Mahmood, M.D., M.P.H.17; Otis B. Rickman, D.O.18; Lance Roller, M.S.1; Cristina Salmon, M.D.17; Samira Shojaee, M.D., M.P.H.1,2; Briana Swanner, B.S.1; Momen M. Wahidi, M.D.19; Charla Walston, B.S.N.18; Gerard A. Silvestri, M.D.20; Lonny Yarmus, D.O.21; Najib M. Rahman, D.Phil.22,23,24; and Fabien Maldonado, M.D.1,2; for the Interventional Pulmonary Outcomes Group;
Source: N Engl J Med 2025;392:2100-2112
Original Article
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Dr. Maen Hussein's Thoughts

Non-inferior in diagnosing malignant or benign lesions, and safer (less pneumothorax). The question remains about the amount of tissue for further testing.

BACKGROUND

Each year, millions of pulmonary nodules are identified incidentally or through lung cancer screening, and many involve biopsy to distinguish cancer from benign processes. Both navigational bronchoscopy and computed tomography–guided transthoracic needle biopsy are commonly used in patients undergoing biopsies of peripheral pulmonary nodules, but the relative diagnostic accuracy of these two approaches is unclear.

METHODS

In this multicenter, randomized, parallel-group, noninferiority trial, we assigned patients with an intermediate-risk or high-risk peripheral pulmonary nodule measuring 10 to 30 mm in diameter to undergo navigational bronchoscopy or transthoracic needle biopsy at seven centers across the United States. The primary outcome was diagnostic accuracy, which was defined as the percentage of patients with biopsies that showed a specific diagnosis (cancer or a specific benign condition) that was confirmed to be accurate through 12 months of clinical follow-up (nonferiority margin, 10 percentage points). Secondary outcomes included procedural complications such as the occurrence of pneumothorax.

RESULTS

Among the 234 patients included in the primary-outcome analysis (5 of whom were lost to follow-up), biopsy resulted in a specific diagnosis that was confirmed to be accurate through month 12 in 94 of 119 patients (79.0%) in the navigational bronchoscopy group and in 81 of 110 patients (73.6%) in the transthoracic needle biopsy group (absolute difference, 5.4 percentage points; 95% confidence interval, −6.5 to 17.2; P=0.003 for noninferiority; P=0.17 for superiority). Pneumothorax occurred in 4 of 121 patients (3.3%) in the navigational bronchoscopy group and in 32 of 113 patients (28.3%) in the transthoracic needle biopsy group and led to the placement of a chest tube, hospital admission, or both in 1 patient (0.8%) and 13 patients (11.5%), respectively.

CONCLUSIONS

The diagnostic accuracy of navigational bronchoscopy was noninferior to that of transthoracic needle biopsy among patients with peripheral pulmonary nodules measuring 10 to 30 mm. (Funded by Medtronic and others; VERITAS ClinicalTrials.gov number, NCT04250194.)

Author Affiliations

1Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville; 2Department of Thoracic Surgery, Vanderbilt University Medical Center, Nashville; 3Section of Pulmonary and Critical Care, Nashville Veterans Affairs Hospital, Nashville; 4Department of Radiology and Radiological Sciences, Vanderbilt University Medical Center, Nashville; 5Department of Biostatistics, Vanderbilt University Medical Center, Nashville; 6Division of Pulmonary and Critical Care Medicine, St. Luke’s Health System, University of Missouri at Kansas City, Kansas City; 7Division of Pulmonary, Critical Care, and Sleep Medicine, University Hospitals, Case Western Reserve University School of Medicine, Cleveland; 8Vanderbilt Trial Innovation Center and Center for Learning Healthcare, Vanderbilt Institute for Clinical and Translational Research, Nashville; 9Division of Pulmonary, Critical Care, Sleep Medicine, and Physiology, University of California at San Diego, La Jolla; 10Vanderbilt University School of Engineering, Nashville; 11Section of Thoracic Surgery, Nashville Veterans Affairs Hospital, Nashville; 12Kootenai Clinic Lung and Asthma, Kootenai Health, Coeur d’Alene, ID; 13Department of Pathology, Vanderbilt University Medical Center, Nashville; 14Division of Pulmonary, Critical Care, and Sleep Medicine, Rush University Medical Center, Chicago; 15Division of Pulmonary, Critical Care, and Sleep Medicine, Medical College of Wisconsin, Milwaukee; 16Division of Pulmonary Medicine, Respiratory Institute, Cleveland Clinic, Cleveland; 17Division of Pulmonary, Allergy, and Critical Care Medicine, Duke University School of Medicine, Durham, NC; 18Chest and Lung Center, Ascension Saint Thomas, Nashville; 19Division of Pulmonary and Critical Care, Northwestern Feinberg School of Medicine, Chicago; 20Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine, Medical University of South Carolina, Charleston; 21Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore; 22Oxford Respiratory Trials Unit, University of Oxford, Oxford, United Kingdom; 23National Institute for Health and Care Research Oxford Biomedical Research Centre, Oxford, United Kingdom; 24Chinese Academy of Medical Sciences Oxford Institute, University of Oxford, Oxford, United Kingdom;

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