NAVIGATIONAL bronchoscopy demonstrated noninferior diagnostic accuracy to transthoracic needle biopsy in evaluating peripheral pulmonary nodules, according to findings from a U.S.-based multicenter trial published June 2025.
In this randomized noninferiority study, researchers compared the two biopsy methods in 234 patients with intermediate- or high-risk peripheral lung nodules measuring 10 to 30 mm. Participants underwent either navigational bronchoscopy or CT-guided transthoracic needle biopsy, with the primary outcome being diagnostic accuracy confirmed through 12 months of clinical follow-up.
The study found that 79.0% of patients who underwent navigational bronchoscopy achieved a confirmed, specific diagnosis, compared to 73.6% in the transthoracic needle biopsy group. This 5.4 percentage point difference (95% CI, −6.5 to 17.2) met the predefined noninferiority threshold of 10 percentage points (P=0.003 for noninferiority), though not superiority (P=0.17).
In addition to comparable accuracy, navigational bronchoscopy was associated with significantly fewer complications. Pneumothorax occurred in just 3.3% of patients in the bronchoscopy group, compared to 28.3% in the transthoracic biopsy group. Of those, 11.5% of transthoracic biopsy patients required chest tube placement or hospital admission, while only 0.8% in the bronchoscopy group required such interventions.
These findings suggest that navigational bronchoscopy may offer a safer diagnostic alternative without sacrificing accuracy in patients with peripheral pulmonary nodules. While not yet shown to be superior, its significantly lower complication rate could influence clinical decision-making, particularly when minimizing procedural risk is a priority.
This trial highlights the evolving landscape of minimally invasive techniques for lung cancer diagnosis and may help guide personalized approaches to nodule evaluation in clinical practice.
Reference:
Lentz RJ et al. Navigational Bronchoscopy or Transthoracic Needle Biopsy for Lung Nodules. N Engl J Med. 2025;392:2100–2112.