Cryobiopsy vs Forceps Biopsy for Lung Disease

(FROSTBITE-2 Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two methods for obtaining lung tissue samples: a new tool called a cryoprobe and the standard tool known as forceps. The researchers seek to determine which method is more effective for diagnosing lung diseases. Individuals scheduled for a bronchoscopy with a transbronchial biopsy may be suitable candidates for this study. Participants will join one of two groups: one using the cryoprobe and the other using the standard forceps for their lung biopsy. As an unphased trial, this study provides participants the chance to contribute to valuable research that could enhance diagnostic methods for lung diseases.

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 prior data suggests that these biopsy methods are safe for lung disease?

Research has shown that the 1.1mm cryoprobe used for lung biopsies is generally well-tolerated. One study found that participants experienced less moderate bleeding with the cryoprobe compared to other methods (6.2% vs. 17.0%). This finding suggests that the cryoprobe might be safer regarding bleeding risk.

However, there is concern about the risk of major bleeding if the biopsy is taken too close to the pleura, the lining around the lungs. Although no studies have directly compared bleeding risks based on the probe's proximity to the pleura, this factor should be considered.

Overall, the cryoprobe appears to be a safe option for lung biopsies, with a lower risk of bleeding compared to traditional methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial comparing cryobiopsy to forceps biopsy for lung disease because cryobiopsy offers a unique approach to obtaining lung tissue samples. Unlike the standard forceps biopsy, cryobiopsy uses a cryoprobe that freezes and extracts a larger and more intact tissue sample. This method could potentially provide more accurate diagnoses and reduce the need for repeated procedures. The hope is that cryobiopsy will enhance diagnostic precision and improve patient outcomes in lung disease management.

What evidence suggests that this trial's treatments could be effective for lung disease?

This trial will compare the effectiveness of two biopsy methods for lung disease: cryobiopsy using a 1.1mm cryoprobe and traditional forceps biopsy. Research has shown that a 1.1mm cryoprobe for lung biopsies is highly effective, correctly identifying the condition in up to 90% of cases. Additionally, cryobiopsy provides a clear diagnosis in 74.4% of cases, compared to only 34.2% with traditional forceps. The cryoprobe method also results in fewer instances of moderate bleeding, occurring in just 6.2% of procedures compared to 17.0% with forceps. Overall, the cryoprobe technique appears to be a safer and more reliable option for diagnosing lung diseases. ^{1 3 4 6 7}

Who Is on the Research Team?

Jeffrey Thiboutot, MD, MHS

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

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

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

I have a bleeding disorder.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38910197/

The Diagnostic Efficiency and Safety of Transbronchial ...

A decreased incidence of moderate bleeding was found in the 1.1-mm cryoprobe group (17.0% vs. 6.2%, p = 0.027), while there was no difference in the incidence ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S0954611123002263

Clinical outcomes of transbronchial cryobiopsy using a 1.1- ...

The new 1.1-mm cryoprobe showed overall diagnostic yield up to 90%. The diagnostic yield showed no difference based on lesion size, RP-EBUS findings, and ...

3.

resmedjournal.com

resmedjournal.com/article/S0954-6111(22)00178-0/fulltext

The safety profile of a protocolized transbronchial ...

This paper looks at the safety and outcomes for cryobiopsy for diffuse parenchymal lung disease. •. We believe this paper would add a good ...

4.

publications.ersnet.org

publications.ersnet.org/content/erj/42/suppl57/p2302

Diagnostic yield of transbronchial cryobiopsy in diffuse lung ...

The pathologists reached a histologic diagnosis in more cases in the cryoprobe group (74.4.%) than in the conventional-forceps group (34.2%) (p < 0.001).

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5542930/

Transbronchial cryobiopsy for diffuse parenchymal lung disease

Transbronchial lung biopsy with a cryoprobe, or cryobiopsy, is a promising new bronchoscopic biopsy technique capable of obtaining larger and better-preserved ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S0954611122001780

The safety profile of a protocolized transbronchial ...

This paper looks at the safety and outcomes for cryobiopsy for diffuse parenchymal lung disease. •. We believe this paper would add a good support for the ...

7.

ccts.amegroups.org

ccts.amegroups.org/article/view/89093/html

The rising role of cryobiopsy in diagnosis of pulmonary disorders

This review aims to address the current known data of the application of cryobiopsy in evaluation of ILD, peripheral lung nodules, and lymph node evaluations.