Medtronic study shows navigated bronchoscopy can avoid needle biopsy complications in diagnoses of lung cancer

A head-to-head study from Medtronic showed that its minimally invasive approach to reaching tissues in the lung suspected of harboring cancer could be just as effective as the current standard of care biopsy, which requires guiding a needle through the skin and into the chest during a CT scan.

The randomized trial evaluated the company’s Illumisite 3D X-ray navigation platform used in combination with electromagnetic navigation bronchoscopy, or ENB, with samples being retrieved via an endoscope threaded down the patient’s throat and into the lungs’ air pockets.

Preliminary data from researchers at Vanderbilt University Medical Center deemed Medtronic’s method as noninferior compared to CT-guided biopsy, with similar rates of lung disease diagnoses—while, at the same time, the minimally invasive route was able to avoid needle-related complications that affect as many as a quarter of real-world procedures.

“These findings suggest that ENB should be the preferred option over CT-guided biopsy for diagnosing indeterminate pulmonary nodules when both approaches are options,” said principal investigator Fabien Maldonado, M.D., who holds the Pierre Massion Directorship in Lung Cancer Research at Vanderbilt-Ingram Cancer Center. 

“ENB enables providers to biopsy and stage multiple lung nodules within a single procedure,” Maldonado said in a statement. “This means one episode of care for patients versus a possible two episodes of care with CT-guided biopsy, potentially reducing delays in patient care and treatment.”

Illumisite also employs digital tomosynthesis imaging to follow the bronchoscope through the body in real time and keep its path on track to the targeted nodule while adjusting for the involuntary movements of the body.

The study included 234 patients and showed the same rates of diagnostic yield between the two biopsy methods, with each reaching 76%. Reviewing pathologists were blinded to how the samples were obtained.

ENB procedures had significantly fewer complications, such as punctures resulting in a collapsed lung, at a rate of 5.8% versus 31% with CT-guided needle biopsy. The results were presented at the annual meeting of the American Thoracic Society in San Diego.

“The findings clearly demonstrate that higher complication rates of CT-guided biopsy should no longer be considered a necessary tradeoff for diagnostic yield,” said Matt Anderson, general manager of advanced surgical technologies at Medtronic. “The reductions in episodes of care and complications with our platform may also reduce the costs of accurate and timely early-stage lung cancer diagnosis.”