In a study (VERITAS) reported in The New England Journal of Medicine, Lentz et al evaluated whether the diagnostic accuracy of navigational bronchoscopy was noninferior to that of transthoracic needle biopsy for malignancy or specific benign conditions in patients with peripheral pulmonary nodules. Pneumothorax was more common with transthoracic needle biopsy.
Study Details
In the U.S. multicenter, open-label, investigator-initiated noninferiority trial, 229 patients with an intermediate- or high-risk peripheral pulmonary nodule with a diameter of 10 to 30 mm were randomly assigned between September 2020 and June 2023 to undergo navigational bronchoscopy (n = 121) or computed tomography–guided transthoracic needle biopsy (n = 113).
The primary outcome measure was diagnostic accuracy, defined as the percentage of patients with biopsies that showed a specific diagnosis of lung cancer or specific benign conditions confirmed to be accurate through 12 months of clinical follow-up; the noninferiority margin was 10 percentage points.
Key Findings
Among evaluable patients, biopsy resulted in a specific diagnosis confirmed to be accurate through month 12 in 94 (79.0%) of 119 patients in the navigational bronchoscopy group and in 81 (73.6%) of 110 patients in the transthoracic needle biopsy group (absolute difference = 5.4 percentage points, 95% confidence interval [CI] = −6.5 to 17.2 percentage points, P = .003 for noninferiority, P = .17 for superiority).
Pneumothorax occurred in 4 (3.3%) of 121 patients in the navigational bronchoscopy group and in 32 (28.3%) of 113 in the transthoracic needle biopsy group; placement of a chest tube, hospital admission, or both occurred in 1 patient (0.8%) in the navigational bronchoscopy group vs 13 (11.5%) in the transthoracic needle biopsy group (absolute risk difference = 10.7 percentage points, 95% CI = 3.7–17.6 percentage points).
The investigators concluded: “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.”
Fabien Maldonado, MD, of the Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, is the corresponding author for the New England Journal of Medicine article.
Disclosure: The study was funded by Medtronic and others. For full disclosures of all study authors, visit the New England Journal of Medicine.
