Cryobiopsy vs Forceps Biopsy for Lung Disease

(FROSTBITE-2 Trial)

Recruiting at 6 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Pregnancy, Pulmonary hypertension, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

500 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial compares a new method to a standard one for lung biopsies. It targets patients needing lung tissue samples, aiming to improve sample quality and reduce complications. The new method works by freezing and removing tissue, providing larger and higher-quality samples with a good safety and cost-benefit profile.

Will I have to stop taking my current medications?

If you are taking blood thinners or medications that prevent blood clots, you may need to stop them before the procedure, unless it's just aspirin. The trial does not specify about other medications.

What data supports the effectiveness of the treatment Cryoprobe for lung disease?

Research shows that cryobiopsy, which uses a cryoprobe, provides larger and better-preserved lung samples compared to forceps biopsy, leading to a higher diagnostic yield for lung diseases. It is also noted to have a lower complication rate than surgical lung biopsy, making it a promising alternative for diagnosing lung conditions. ^{1 2 3 4 5}

Is cryobiopsy safe compared to forceps biopsy for lung disease?

Cryobiopsy is generally safe for obtaining lung tissue samples, with a lower incidence of severe bleeding and serious adverse events (4%) compared to expected rates. It provides larger tissue samples than forceps biopsy, which can be beneficial for diagnosis and analysis. ^{4 6 7 8 9}

How does the cryobiopsy treatment differ from forceps biopsy for lung disease?

Cryobiopsy is unique because it provides larger and better-preserved lung tissue samples compared to forceps biopsy, which can lead to a higher diagnostic yield. It is also less invasive than surgical lung biopsy, making it suitable for patients who cannot undergo surgery. ^{1 4 7 8 10}

Research Team

Jeffrey Thiboutot, MD, MHS

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for adults over 18 who need a lung biopsy as part of their usual care. It's not for those with bleeding disorders, severe heart or lung conditions, recent strokes or heart attacks, low platelet counts, or women who could be pregnant and won't test. People on certain blood thinners can't join.

Inclusion Criteria

I am scheduled for a lung biopsy through a bronchoscopy.

I am 18 years old or older.

Exclusion Criteria

I cannot stop my blood thinner medication before a surgery as recommended.

I have a bleeding disorder.

You have a Do Not Resuscitate (DNR) order in place.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a transbronchial biopsy using either a cryoprobe or forceps

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the biopsy procedure

4 weeks

1 visit (in-person), additional follow-up via phone

Treatment Details

Interventions

• Cryoprobe
• Forceps

Trial Overview The study is testing if using a smaller cryoprobe (1.1mm) to take lung tissue samples is as effective as the standard larger forceps (2.0mm). Participants will undergo bronchoscopy where either the cryoprobe or forceps will be used for biopsy.

Participant Groups

Group I: Cryoprobe Experimental Treatment 1 Intervention

Participants in this arm will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe

Group II: Forceps Active Control 1 Intervention

Participants in this arm will undergo a standard of care bronchoscopy with a transbronchial biopsy using forceps

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Erbe USA Incorporated

Collaborator

Trials

12

Recruited

1,300+

Findings from Research

Cryobiopsy, a new bronchoscopic technique for lung biopsy, can obtain larger and better-preserved tissue samples than traditional methods, with a diagnostic yield of 70% to 80% for diffuse parenchymal lung disease.

The variability in cryobiopsy techniques and definitions of diagnostic yield across different centers makes it challenging to compare results and assess complications, highlighting the need for standardized protocols and further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transbronchial cryobiopsy for diffuse parenchymal lung disease: a state-of-the-art review of procedural techniques, current evidence, and future challenges. Lentz, RJ., Argento, AC., Colby, TV., et al.[2020]

In a study involving 60 patients, both the 1.7-mm and 1.9-mm cryoprobes used for transbronchial lung cryobiopsy showed similar high diagnostic yields (100% for the 1.9-mm and 93.3% for the 1.7-mm), indicating that both tools are effective for diagnosing diffuse parenchymal lung diseases.

The safety profiles of both cryoprobes were comparable, with no significant differences in complication rates, such as pneumothorax or bleeding, and no severe adverse events reported, suggesting that both methods are safe for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic yield and safety of transbronchial lung cryobiopsy for diffuse parenchymal lung diseases diagnosis: Comparison between 1.7-mm and 1.9-mm probes. Ravaglia, C., Sultani, F., Piciucchi, S., et al.[2023]

Transbronchial cryobiopsies taken for 3 seconds yield the largest biopsy size while minimizing complications, such as severe bleeding and pneumothorax, based on a study involving two anesthetized sheep and 49 biopsies.

The study found a significant positive correlation between freezing time and biopsy size, with all samples showing preserved lung tissue architecture and minimal artefacts, indicating the method's efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Transbronchial Lung Cryobiopsy Size and Freezing Time: A Prognostic Animal Study. Ing, M., Oliver, RA., Oliver, BG., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Transbronchial Cryobiopsy in the Diagnosis of Diffuse Lung Disease. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Cryobiopsy vs. Forceps Biopsy for Interstitial Lung Diseases, Lung Tumors, and Peripheral Pulmonary Lesions: An Updated Systematic Review and Meta-Analysis. [2022]

3. China pubmed.ncbi.nlm.nih.gov

Transbronchial cryobiopsy for diffuse parenchymal lung disease: a state-of-the-art review of procedural techniques, current evidence, and future challenges. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Cryoprobe biopsy increases the diagnostic yield in endobronchial tumor lesions. [2010]

5. Australia pubmed.ncbi.nlm.nih.gov

Efficacy and safety of cryobiopsy versus forceps biopsy for interstitial lung diseases and lung tumours: A systematic review and meta-analysis. [2022]

6. Spain pubmed.ncbi.nlm.nih.gov

Diagnostic yield and safety of transbronchial lung cryobiopsy for diffuse parenchymal lung diseases diagnosis: Comparison between 1.7-mm and 1.9-mm probes. [2023]

7. China pubmed.ncbi.nlm.nih.gov

Quality of transbronchial biopsy with large forceps compared to cryobiopsy: a randomized controlled, single blinded live animal study. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of Transbronchial Lung Cryobiopsy Size and Freezing Time: A Prognostic Animal Study. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Feasibility and utility of transbronchial cryobiopsy in precision medicine for lung cancer: Prospective single-arm study. [2020]

10. Romania pubmed.ncbi.nlm.nih.gov

Different protocols for cryobiopsy versus forceps biopsy in diagnosis of patients with endobronchial tumors. [2013]