In a new study published in JAMA, the diagnostic yield of transbronchial lung biopsy was significantly higher when using a cryoprobe versus forceps in a group of patients with pulmonary nodules or masses, recent lung transplant, and diffuse parenchymal lung disease.

A transbronchial lung biopsy is a minimally invasive procedure in which a bronchoscope — a thin, lighted tube — is guided through the nose or mouth into the lungs. Tools are then passed through the scope to collect tissue for laboratory analysis to diagnose lung conditions. A cryoprobe is a medical instrument that uses localized freezing to extract tissue. Forceps are used to pinch off tissue for removal, which can be faster but also crushes a portion of the tissue sample.

The FROSTBITE-2 randomized trial showed diagnostic yield during transbronchial biopsy was nearly 10 percentage points higher when performed using a 1.1-millimeter cryoprobe rather than with 2.0-millimeter forceps (88.6% vs 78.8%). The difference was particularly great among patients with pulmonary nodules or masses (83.2% vs 70.1%). In a secondary safety analysis, there were four pneumothoraces (collapsed lungs) requiring chest tube placement in the forceps group (1.6%) compared to none in the cryoprobe group. No patients experienced significant bleeding or respiratory failure events.

“A structurally intact, sufficiently large tissue sample from a targeted area in the lung increases the likelihood of an accurate diagnosis, which is what we strive for every time we perform a transbronchial lung biopsy,” said interventional pulmonologist Fabien Maldonado, MD, MSc, Professor of Medicine and Thoracic Surgery, and Director of Interventional Pulmonology at the Vanderbilt Lung Institute.

“We’re continually investigating ways we can improve these procedures, as accurate diagnoses up-front save time, which may help get patients the treatment they need faster. Evaluating the tools we use, particularly as innovations in this area occur, is an important avenue of investigation.

“Individuals who have known or suspected lung issues deserve to have the best possible diagnostic procedures, so they and their clinical teams have clear evidence of what is occurring in their lungs so informed treatment decisions can be made.”

Previous studies using a 1.9-millimeter cryoprobe have yielded larger lung tissue specimens at higher quality without crushing the sample, but there were also more bleeding and pneumothorax events. The FROSTBITE-2 trial used the 1.1-millimeter cryoprobe probe which, unlike the larger probes, is small enough to remove the biopsy specimen through the working channel without having to remove the scope, which increases safety.

Certain lots of the cryoprobe went under a Food and Drug Administration Class I recall in March due to reports of rupturing or bursting during activation; none of these events were reported in this trial.

The study was conducted under the auspices of the Interventional Pulmonary Outcomes Group, an international collaborative of clinical experts dedicated to improving patient care in interventional pulmonology through multicenter clinical trials and research. Maldonado, who holds the Pierre Massion Directorship in Lung Cancer Research at Vanderbilt Health, is vice chair of this group.

The trial was completed at nine U.S. medical centers including Vanderbilt Health that perform at least 100 transbronchial biopsies annually and have affiliated institutional centers for lung cancer, lung transplant and interstitial lung disease. Patients enrolled were 18 or older and scheduled to undergo transbronchial biopsy for lung nodules or masses, lung transplant, or diffuse parenchymal lung disease. Five hundred individuals were randomly assigned to either the 1.1-millimeter cryoprobe or the 2.0-millimeter forceps for the biopsy.

“These promising results bring us one step closer to making these vital diagnostic procedures even more safe, accurate and effective,” said Vanderbilt Health interventional pulmonologist Robert Lentz, MD, Associate Professor of Medicine and Thoracic Surgery. “Our team is currently conducting FROSTBITE-3, a randomized controlled trial comparing the 1.1-millimeter cryoprobe with instruments for lymph node biopsies, to determine whether this novel tool may help with molecular testing in patients diagnosed with lung cancer.

The FROSTBITE-2 study is an investigator-initiated trial. It was funded by Erbe, an international business that develops, manufactures and markets surgical systems. The funder had no role in trial design, data collection, data analysis, manuscript preparation, or the decision to publish.

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Navigational bronchoscopy is as effective as the traditionally used transthoracic needle biopsy for diagnosing lung nodules, but with significantly fewer complications, per a new study published May 18 in the New England Journal of Medicine. This development may shift medical practice and reduce hospitalizations for patients undergoing lung nodule biopsies, said researchers.  

Each year, millions of lung nodules are detected during routine X-rays or CT scans. While most nodules are benign, some are cancerous and when found at this stage they are the earliest and most curable stage of lung cancer.   

Accurate biopsy of lung nodules is often required to tell benign nodules from malignant ones. To date, the most commonly used method, CT-guided transthoracic needle biopsy, carries a high complication rate — including pneumothorax, or partial lung collapse, affecting about 25% of patients. Treatment of the partially collapsed lung often requires a chest tube during a multiple day inpatient stay.  

This study is the first to directly compare these biopsy techniques and the results are compelling, said first author Robert Lentz, MD, associate professor of Medicine and Thoracic Surgery in the Division of Allergy, Pulmonary and Critical Care Medicine at Vanderbilt University Medical Center. The study, conducted across seven centers in the United States, compared the two techniques in a multicenter, randomized trial involving 234 patients with lung nodules between 10-30 mm.  

Navigational bronchoscopy uses a sophisticated targeting system and 3D imaging to guide biopsy tools through small peripheral airways directly to a lung nodule.   

The comparison revealed a diagnostic accuracy of 79% using navigational technology, closely matching the 74% accuracy of transthoracic biopsy. More importantly, the risk of pneumothorax was significantly lower, occurring in only 3% of bronchoscopy patients compared to 35% in those undergoing transthoracic biopsy. Severe cases requiring hospital admission or chest tube insertion were less than 1% with bronchoscopy, as opposed to 14% with the traditional method.  

“With approximately 300,000 lung nodule biopsies performed annually in the U.S., shifting to navigational bronchoscopy could greatly reduce complications and hospital stays. This study confirms its diagnostic efficacy and superior safety profile, making it the preferred choice for lung nodule diagnosis,” said senior author Fabien Maldonado, MD, MSc, professor of Medicine and Thoracic Surgery and director of Interventional Pulmonology.  

The research team plans to continue exploring optimal biopsy techniques, comparing different navigational and robotic bronchoscopy systems, and studying novel biopsy tools, said Maldonado, Pierre Massion Director in Lung Cancer Research.  

They are also involved in research on bronchoscopic ablation of lung cancer, advancing the field of interventional pulmonology.  

“As a relatively new medical subspecialty, we are quite proud and excited to have matured our research infrastructure to the point of being able to produce high quality multicenter trials like this, and hope that publication of this trial will serve as an introduction of sorts for interventional pulmonology to the larger general medical audience,” said Lentz.   

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