VERITAS
Trial question
Is navigational bronchoscopy noninferior to transthoracic needle biopsy in patients with peripheral pulmonary nodules?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
48.0% female
52.0% male
N = 234
234 patients (113 female, 121 male).
Inclusion criteria: patients with an intermediate- or high-risk peripheral pulmonary nodule measuring 10-30 mm in diameter.
Key exclusion criteria: nodule accessible without navigation; separate condition for which linear endobronchial ultrasound-guided needle aspiration was indicated; planned empirical treatment with stereotactic body radiation therapy regardless of biopsy results; biopsy not feasible by means of either navigational bronchoscopy or transthoracic needle biopsy.
Interventions
N=121 navigational bronchoscopy (electromagnetic navigational bronchoscopy with integrated digital tomosynthesis).
N=113 transthoracic needle biopsy (CT-guided transthoracic needle biopsy under local anesthesia with moderate sedation or under general anesthesia).
Primary outcome
Rate of diagnostic accuracy through month 12
79%
73.6%
79.0 %
59.3 %
39.5 %
19.8 %
0.0 %
Navigational
bronchoscopy
Transthoracic needle
biopsy
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in the rate of diagnostic accuracy through month 12 (79% vs. 73.6%; AD 5.4%, 95% CI -6.5 to 17.2).
Secondary outcomes
No significant difference in diagnostic yield (79.3% vs. 77.9%; AD 1.5%, 95% CI -9.9 to 12.8).
Significant increase in median duration of procedure (36 minutes vs. 25 minutes; AD 11 minutes, 95% CI 8 to 18).
Significant increase in intraprocedural rapid onsite cytologic assessment (95.8% vs. 7.2%; AD 88.6%, 95% CI 81.4 to 95.8).
Safety outcomes
No significant differences in median duration of chest tube in place, respiratory failure resulting in hospital admission, acute coronary syndrome.
Significant differences in procedural complications (5.0% vs. 29.2%), pneumothorax (3.3% vs. 28.3%).
Conclusion
In patients with an intermediate- or high-risk peripheral pulmonary nodule measuring 10-30 mm in diameter, navigational bronchoscopy was noninferior to transthoracic needle biopsy with respect to the rate of diagnostic accuracy through month 12.
Reference
Robert J Lentz, Katherine Frederick-Dyer, Virginia B Planz et al. Navigational Bronchoscopy or Transthoracic Needle Biopsy for Lung Nodules. N Engl J Med. 2025 May 18. Online ahead of print.
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