Transbronchial biopsy with 1.1-mm cryoprobe yields 88.6% diagnosis versus 78.8% with 2.0-mm forcepsCryoprobe biopsy shows higher success rate for diagnosing lung conditions

JAMA Published June 18, 2026 Study authors: Thiboutot Jeffrey, Kapp Christopher M, Illei Peter, Shofer Scott, Gilbert Christopher R, DiBardino D… PubMed ↗ NCT05751278 ↗ DOI ↗ Editorial oversight: Dr. Julia Lee, PhD · Oncology, Genomics & Drug Development

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Key Takeaway

Consider 1.1-mm cryoprobes for higher diagnostic yields in lung nodules and transplant cases compared to 2.0-mm forceps.

This randomized clinical trial evaluated the efficacy of a 1.1-mm cryoprobe compared to standard 2.0-mm forceps for transbronchial biopsy. The study enrolled 500 patients aged 18 years or older across 9 medical centers in the United States. The patient population included individuals scheduled for transbronchial biopsy due to lung nodules or masses, lung transplant, or diffuse parenchymal lung disease.

The intervention group received a transbronchial biopsy using a 1.1-mm cryoprobe, while the comparator group received a biopsy using 2.0-mm forceps. The primary outcome measure was the diagnostic yield, defined as the percentage of patients whose biopsy samples led to a specific diagnosis based on histologic examination.

For the primary outcome, the cryoprobe group achieved a diagnostic yield of 88.6% compared to 78.8% in the forceps group. This represents an absolute difference of 9.8% (217 of 245 vs 193 of 245). The result was statistically significant with a 95% CI of 3.3% to 16.3% and a p-value of.003.

Secondary outcomes provided more granular data across specific conditions. For lung nodules or masses, the cryoprobe group showed a diagnostic yield of 83.2% compared to 70.1% in the forceps group (absolute difference, 13.1%; 79 of 95 vs 68 of 97; 95% CI, 1.0% to 24.6%; P =.04). For lung transplant patients, the cryoprobe yield was 96.0% compared to 88.7% in the forceps group (absolute difference, 7.3%; 120 of 125 vs 110 of 124; 95% CI, 0.6% to 14.4%; P =.03). However, for patients with diffuse parenchymal lung disease, the cryoprobe yield was 72.0% compared to 62.5% in the forceps group (absolute difference, 9.5%; 18 of 25 vs 15 of 24), but this did not reach statistical significance (95% CI, -16.0% to 33.6%; P =.55).

Safety and tolerability data indicated that the cryoprobe may have a favorable safety profile in certain aspects. Specifically, there were no pneumothoraces in the cryoprobe group, whereas 4 pneumothoraces requiring chest tube placement occurred in the forceps group (1.6%). No patients in either group experienced significant bleeding or respiratory failure events.

These results suggest that the 1.1-mm cryoprobe provides a statistically superior diagnostic yield for lung nodules and transplant cases compared to 2.0-mm forceps. While the study did not find a statistically significant difference in diagnostic yield for diffuse parenchymal lung disease, the overall primary outcome was positive.

The clinical implications suggest that clinicians may prefer the 1.1-mm cryoprobe to improve diagnostic yields in patients with nodules or transplant requirements. Limitations include the lack of statistical significance specifically for the diffuse parenchymal lung disease subgroup. Questions remain regarding the long-term durability of these findings across a broader range of pulmonary pathologies and whether the smaller sample size in the diffuse parenchymal lung disease group (n=25 vs n=24) limited the ability to detect differences.

When patients are diagnosed with lung nodules, masses, or other serious lung diseases, getting a clear diagnosis is a critical first step. Doctors often use a procedure called a transbronchial biopsy to take samples from the lungs. This information helps doctors decide on the best treatment plan for the patient. Because accurate results are so important, researchers looked at different tools used during this procedure to see which one provides the most reliable information.

In this large study, researchers enrolled 500 patients across nine medical centers in the United States. These patients were scheduled to undergo a transbronchial biopsy because of conditions like lung nodules or issues related to lung transplants. The researchers split the group into two: one group received a biopsy using a small 1.1-mm cryoprobe, and the other group used a standard 2.0-mm forceps tool. The goal was to see which method gave a better diagnostic yield, which means the percentage of tests that actually provided enough information for a clear diagnosis.

The results showed that the cryoprobe performed well in several categories. For patients with lung nodules or masses, the cryoprobe had a success rate of 83.2% compared to 70.1% for the forceps. In cases involving lung transplants, the cryoprobe reached a 96.0% success rate, while the forceps were at 88.7%. Overall, the primary diagnostic yield was significantly higher for the cryoprobe group at 88.6% compared to 78.8% for the forceps. However, it is important to note that for patients with diffuse parenchymal lung disease, there was no significant difference in success rates between the two tools.

Safety was also a factor in the study. The researchers found that none of the patients who received the cryoprobe experienced a pneumothorax, which is a collapsed lung. In contrast, four patients in the forceps group experienced a collapsed lung and required a chest tube. No patients in either group suffered from significant bleeding or respiratory failure.

While these results are promising for doctors choosing tools for lung biopsies, it is important to remember that this is one study involving specific medical settings. While the cryoprobe showed better results for nodules and transplants, the evidence was not as strong for other types of lung disease. Patients should talk with their specialists about which biopsy method is best suited for their specific condition and medical history.

What this means for you:

A smaller cryoprobe may provide more accurate diagnoses for certain lung conditions than standard forceps tools.

Study Details

Study typeRct

Sample sizen = 500

EvidenceLevel 2

Follow-up216.0 mo

PublishedJun 2026

PMID42149700

TrialNCT05751278

View Original Abstract ↓

IMPORTANCE: Bronchoscopic biopsy is conventionally performed with forceps, which can result in small specimen sizes and poor specimen quality due to crush artifact. Cryoprobe use localizes freezing at the probe tip, enabling retrieval of larger, more intact biopsy specimens. OBJECTIVE: To evaluate the diagnostic yield of a 1.1-mm cryoprobe for transbronchial biopsy. DESIGN, SETTING, AND PARTICIPANTS: This open-label, outcome assessor-masked, multicenter randomized clinical trial included 500 patients aged 18 years or older scheduled to undergo transbronchial biopsy for lung nodules or masses, lung transplant, or diffuse parenchymal lung disease. The trial was conducted in 9 US medical centers and enrolled patients between February 27, 2023, and September 11, 2024. The date of last follow-up was October 12, 2024. INTERVENTION: Patients were randomized 1:1 to transbronchial biopsy using a 1.1-mm cryoprobe (n = 250) or 2.0-mm forceps (n = 250). MAIN OUTCOMES AND MEASURES: The primary outcome was diagnostic yield, defined as the percentage of patients for whom the transbronchial biopsy sample led to a specific diagnosis based on histologic examination. Of the 8 prespecified secondary analyses, key secondary analyses were the diagnostic yield for each of the 3 conditions (lung nodules or masses, lung transplant, and diffuse parenchymal lung disease) and complication rates. RESULTS: Of 774 patients assessed for eligibility, 609 provided consent, 500 were randomized, and 490 were included in the primary analysis; the mean age was 62.6 years (SD, 12.7 years) and 252 of 500 (50.4%) were male. The primary outcome of diagnostic yield was significantly higher in patients randomized to transbronchial biopsy with cryoprobes vs forceps (217 of 245 [88.6%] vs 193 of 245 [78.8%]; absolute difference, 9.8%; 95% CI, 3.3%-16.3%; P = .003). For the key secondary analyses, compared with that of forceps, the diagnostic yield of cryoprobes was significantly higher among patients with pulmonary nodules or masses (79 of 95 [83.2%] vs 68 of 97 [70.1%]; absolute difference, 13.1%; 95% CI, 1.0%-24.6%; P = .04) and lung transplant (120 of 125 [96.0%] vs 110 of 124 [88.7%]; absolute difference, 7.3%; 95% CI, 0.6%-14.4%; P = .03) but did not differ significantly in diffuse parenchymal lung disease (18 of 25 [72.0%] vs 15 of 24 [62.5%]; absolute difference, 9.5%; 95% CI, -16.0% to 33.6%; P = .55). For the secondary safety analysis, there were 4 pneumothoraces requiring chest tube placement in the forceps group (1.6%) vs none in the cryoprobe group; no patients experienced significant bleeding or respiratory failure events. CONCLUSIONS AND RELEVANCE: Transbronchial lung biopsy performed with a 1.1-mm cryoprobe had a significantly higher diagnostic yield compared with 2.0-mm forceps in a group of patients with lung nodules or masses, lung transplant, and diffuse parenchymal lung disease. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05751278.

Transbronchial biopsy with 1.1-mm cryoprobe yields 88.6% diagnosis versus 78.8% with 2.0-mm forcepsCryoprobe biopsy shows higher success rate for diagnosing lung conditions

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Transbronchial biopsy with 1.1-mm cryoprobe yields 88.6% diagnosis versus 78.8% with 2.0-mm forcepsCryoprobe biopsy shows higher success rate for diagnosing lung conditions

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