In a new study published in Japan Automobile Manufacturers Associationin a group of patients with pulmonary nodules or masses, recent lung transplantation, and diffuse parenchymal lung disease, the diagnostic yield of transbronchial lung biopsy was significantly higher when using a cryoprobe versus using forceps.
Transbronchial lung biopsy is a minimally invasive procedure in which a bronchoscope (a thin, lighted tube) is guided into the lungs through the nose or mouth. The tool is then passed through an endoscope to collect tissue for laboratory analysis to diagnose the lung condition. A cryoprobe is a medical device that uses localized freezing to extract tissue. Forceps are used to pinch and remove tissue. This can be done more quickly, but will crush some of the tissue sample.
If we can obtain a structurally intact and large enough tissue sample from the target area of the lung, we increase the likelihood of an accurate diagnosis, and that is what we strive for every time we perform a transbronchial lung biopsy. ”
Fabian Maldonado, MD, MS, interventional pulmonologist, professor of medicine and thoracic surgery, director of interventional pulmonology, Vanderbilt Lung Institute
“We are continually investigating ways to improve these procedures, as accurate diagnosis upfront can save time and help patients get the treatment they need sooner. Evaluating the tools we use is an important research avenue, especially as innovations occur in this field.”
“People who know or suspect they have a problem with their lungs deserve the best possible diagnostic procedures, so they and their clinical teams have clear evidence of what is happening in their lungs so they can make informed treatment decisions.”
Previous studies using a 1.9-millimeter cryoprobe yielded higher quality and larger lung tissue specimens without disrupting the sample, but also resulted in more bleeding and pneumothorax. The FROSTBITE-2 study used a 1.1-millimeter cryoprobe probe. This increases safety because, unlike larger probes, it is small enough that the biopsy specimen can be removed through the working channel without removing the scope.
We recall that a particular lot of cryoprobes was subject to a Food and Drug Administration class in March due to reports of rupture or rupture during operation. None of these events were reported in this study.
This study was conducted under the auspices of the Interventional Pulmonary Outcomes Group, an international collaboration of clinical experts dedicated to improving patient care in interventional pulmonology through multicenter clinical trials and research. Maldonado is the Pierre Massion Director of Lung Cancer Research at Vanderbilt Health and vice chair of the group.
The study was completed at nine medical centers in the United States, including Vanderbilt Health, which performs at least 100 transbronchial biopsies per year and has affiliated centers for lung cancer, lung transplantation, and interstitial lung disease. Patients enrolled were 18 years of age or older and scheduled to undergo transbronchial biopsy for pulmonary nodules or masses, lung transplantation, or diffuse parenchymal lung disease. Five hundred people were randomly assigned to receive either a 1.1-millimeter cryoprobe or 2.0-millimeter forceps for biopsy.
“These promising results bring us one step closer to making these important diagnostic procedures even safer, more accurate, and more effective,” said Robert Lentz, MD, interventional pulmonologist and associate professor of medicine and thoracic surgery at Vanderbilt Health. “Our team is currently conducting FROSTBITE-3, a randomized controlled trial comparing a 1.1-millimeter cryoprobe and a device for lymph node biopsy to determine whether this new tool can be useful for molecular testing of patients diagnosed with lung cancer.”
The FROSTBITE-2 study is an investigator-initiated trial. Funding was received from Elbe, an international company that develops, manufactures, and sells surgical systems. The funders had no role in study design, data collection, data analysis, manuscript preparation, or decision to publish.
sauce:
Vanderbilt University Medical Center
Reference magazines:
Thibuto, J. Others. (2026) Cryobiopsy and forceps for bronchoscopic lung biopsy: FROSTBITE-2 randomized clinical trial. jam. DOI: 10.1001/jama.2026.7908. https://jamanetwork.com/journals/jama/article-abstract/2849314
