Navigational bronchoscopy safer than CT-guided biopsy in lung nodule diagnosis
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Key takeaways:
- Diagnostic yield was comparable between navigational bronchoscopy and CT-guided biopsy.
- Trial investigator recommends navigational bronchoscopy for lung nodule biopsy based on study findings.
SAN DIEGO — Fewer patients with lung nodules had complications during a navigational bronchoscopy procedure vs. a CT-guided biopsy, according to research presented at the American Thoracic Society International Conference.
Electromagnetic navigation bronchoscopy was performed via the Illumisite fluoroscopic navigation platform (Medtronic) with digital tomosynthesis, according to a company press release.
“When both CT-guided biopsy and navigational bronchoscopy are options for a given nodule, our data suggest that navigational bronchoscopy with integrated digital tomosynthesis should be the preferred option for lung nodule biopsy,” Fabien Maldonado, MD, MSc, overall principal investigator at Vanderbilt-Ingram Cancer Center, told Healio. “VERITAS demonstrated that the diagnostic yield is similar for the two approaches, and that navigational bronchoscopy has a lower rate of complications, specifically the rate of lung collapse.”
In the multicenter, noninferiority randomized controlled VERITAS trial, Maldonado and colleagues evaluated 234 patients with lung nodules sized between 10 mm to 30 mm (median, 15 mm) and a biopsy referral to determine differences in diagnostic yield and safety between those who underwent navigational bronchoscopy (n = 121) and those who underwent CT-guided transthoracic needle biopsy (CT-TTNB; n = 113).
“We carefully designed the study to include academic practices, high-volume practices and community centers,” Maldonado said. “The results reflect a broad range of navigational skills and practice settings, making this study generalizable to other centers.”
Two common nodule characteristics in this population included peripheral third (88%) and solid (82%). A bronchus sign was observed in one-third (33%) of patients.
In order for the interventions to be diagnostic, researchers said it had to have “specific histological findings explaining the presence of a nodule.”
The proportion of patients with a diagnostic result was comparable between the navigational bronchoscopy group and the CT-TTNB group (both 76%), and the noninferiority threshold was crossed based on the 97% probability that navigational bronchoscopy was noninferior to CT-TTNB.
Switching to safety, researchers observed a significantly lower proportion of patients with complications in the navigational bronchoscopy group vs. the CT-TTNB group (5.8%; n = 7 vs. 31%; n = 35; P < .001).
A common complication among those who underwent CT-TTNB was pneumothorax not requiring thoracostomy (n = 22 vs. navigational bronchoscopy, n = 3). The rest of the complications in this group were either identified as pneumothorax requiring tube thoracostomy (n = 10 vs. n = 1) or hemorrhage (n = 3 vs. n = 0).
“We now have randomized controlled data comparing modern navigational bronchoscopy to CT-guided biopsy,” Maldonado said. “CT-guided biopsy traditionally has been viewed as the gold standard because the reported diagnostic yield metrics are in the range of 85% to 90%, but until now, the data available for CT-guided biopsy suffered from the same limitations inherent in noncomparative studies.”
Maldonado told Healio these results confirmed those already found in their published studies.
“We’ve been using navigational bronchoscopy to biopsy suspicious lesions in the lung for a long time,” Maldonado said. “With the Illumisite platform, we now have the added ability to visualize the lesion during the procedure with digital tomosynthesis and correct for CT-body divergence.
“The addition of intra-procedural imaging resulted in a nearly 25-point increase in diagnostic yield at our institution,” he added. “This allowed us to approach the diagnostic yield of CT-guided biopsy, which has been the gold standard in lung nodule biopsy until now.”
When discussing additional advantages of navigational bronchoscopy, Maldonado highlighted its ability to sample multiple nodules.
“Navigational bronchoscopy allows for sampling of mediastinal lymph nodes, or multiple nodules, in the same procedure, which is often needed,” he said. “The main advantage here is that we may save the patient some time in terms of time to diagnosis and time to treatment if they are shown to have lung cancer. The shorter the time to treatment, the better the outcome.”
More data from this trial, specifically comparing the diagnostic accuracy between the two interventions at a 12-month follow-up visit, are expected in the summer of 2024, according to a Medtronic press release.
“Most published data on modern navigational bronchoscopy have been noncomparative in nature, consisting mostly of single-arm, observational studies, from which firm conclusions on the diagnostic utility of a given platform are difficult to draw,” Maldonado said. “VERITAS sets a precedent for comparative research in bronchoscopy and will hopefully motivate future similar studies to better inform patient care and improve outcomes.”
References:
- Lentz RJ, et al. Am J Respir Crit Care Med. 2024;doi:10.1154/ajrccm-conference.2024.209.1_MeetingAbstracts.A6665.
- VERITAS study shows Medtronic fluoroscopic navigation platform offers a safer lung biopsy experience and the same diagnostic yield as CT-guided biopsy. https://news.medtronic.com/VERITAS-study-shows-Medtronic-fluoroscopic-navigation-platform-offers-a-safer-lung-biopsy-experience-and-the-same-diagnostic-yield-as-CT-guided-biopsy. Published May 21, 2024. Accessed May 30, 2024.