Cryoprobe vs Forceps Biopsy for Lung Transplant Rejection

Overseen By John Joerns, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Bleeding diathesis, Low platelets, Pregnancy, others

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

Compensation: Varies

Number of Visits: 2

Duration: Baseline

100 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial requires that you stop taking certain blood thinners (anticoagulation or antiplatelet therapy) before the procedure, but aspirin alone is okay. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

What data supports the effectiveness of the treatment Cryoprobe Biopsy for lung transplant rejection?

Research shows that cryoprobe biopsies provide larger tissue samples and have a higher diagnostic rate for lung transplant rejection compared to traditional forceps biopsies, although they may have a slightly higher risk of complications like bleeding. ^{1 2 3 4 5}

Is cryoprobe biopsy safe for humans?

Cryoprobe biopsy is generally safe for humans, but it may have a higher risk of complications like bleeding compared to forceps biopsy. Studies show that while it provides larger and better-quality tissue samples, the major complication rate is around 9%, with some cases of bleeding and pneumothorax (collapsed lung). ^{1 2 3 4 6}

How does the cryoprobe biopsy treatment differ from other treatments for lung transplant rejection?

Cryoprobe biopsy is unique because it uses a freezing technique to obtain larger tissue samples compared to the traditional forceps biopsy, which often results in smaller and potentially damaged samples. This method may provide more accurate diagnostic information, although it can be associated with more complications. ^{1 2 3 7 8}

What is the purpose of this trial?

The goal of this clinical trial is to evaluate which biopsy collection method helps to better diagnose rejection and relevant pathologic findings in lung transplant recipients. The main questions it aims to answer are: Does the 1.1 mm cryoprobe or the biopsy forceps provide better quality samples of lung tissue for detecting rejection in transplant recipients? How much tissue is adequate for lung transplant 1.1 mm cryobiopsy samples as compared to biopsy forceps? Which samples received by the pathologist did they find they were most confident to exclude rejection, based on their satisfaction with the samples? Which collection method has the least amount of procedural time? Researchers will compare lung tissue samples obtained using a 1.1mm cryoprobe and a biopsy forceps during the lung transplant. Participants will: Be randomly assigned to receive either the cryoprobe or biopsy forceps collection method at the time of biopsy. Assessed for any adverse events following the biopsy for up to 30 days after transplant.

Research Team

John Joerns

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for lung transplant recipients who are being evaluated for rejection. Participants will be randomly assigned to have their biopsy samples collected either with a cryoprobe or traditional forceps during the lung transplant procedure.

Inclusion Criteria

Be willing and able to sign the informed consent

I am scheduled for a lung biopsy after a transplant.

Exclusion Criteria

Do Not Resuscitate (DNR) status

Do Not Intubate (DNI) status

Platelet count <50,000 per μL within 14 days of the biopsy procedure

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo biopsy using either cryoprobe or biopsy forceps to evaluate tissue sample quality

Baseline

1 visit (in-person)

Follow-up

Participants are monitored for adverse events following the biopsy

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Cryoprobe Biopsy
• Forceps Biopsy

Trial Overview The study is testing if a 1.1 mm cryoprobe or standard biopsy forceps provide better quality lung tissue samples for detecting rejection in lung transplant patients. It also compares procedural time and pathologist confidence in diagnosing based on the sample quality.

Participant Groups

Group I: Cryoprobe Biopsy Method Experimental Treatment 1 Intervention

Cryoprobes which are flexible catheters that can be passed through the channel of a bronchoscope. Rapid cooling of tissue results from the Joule-Thomson effect which causes tissue to freeze and adhere to the probe. The biopsy is obtained by subsequently avulsing small fragments of tissue.

Group II: Forceps Biopsy Method Active Control 1 Intervention

Olympus disposable EndoJaw is used to obtain samples as per the standard of clinical care usually resulting in crush artifact.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Optimization of Transbronchial Cryobiopsy in Lung Transplant Recipients. [2023]

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

Cryoprobe transbronchial lung biopsy in patients after lung transplantation: a pilot safety study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The role of transbronchial cryobiopsy in lung transplantation. [2019]

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

Transbronchial Cryobiopsies in Lung Allograft Recipients for Surveillance Purposes: Initial Results. [2020]

5. 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]

6. England pubmed.ncbi.nlm.nih.gov

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

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

Transbronchial Lung Cryobiopsy for Interstitial Lung Disease Diagnosis: A Perspective From Members of the Pulmonary Pathology Society. [2020]

8. Romania pubmed.ncbi.nlm.nih.gov

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