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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the better method for collecting lung tissue samples to detect rejection in lung transplant recipients. Researchers are comparing two techniques: the cryoprobe, which freezes tissue to obtain a sample, and biopsy forceps, a common tool for grabbing small tissue pieces. They seek to identify which method provides clearer and more reliable results, requires less time, and has fewer side effects. The trial seeks lung transplant recipients scheduled for a lung biopsy who can consent to participate. As an unphased trial, this study offers participants the opportunity to contribute to improving post-transplant care techniques.

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

Research has shown that cryoprobe biopsies are generally well-tolerated. In a small study involving 21 procedures, researchers found the cryoprobe method for lung biopsies safe for patients who have had a lung transplant. Participants did not report any major problems. Additionally, cryoprobe biopsies usually provide larger tissue samples, aiding doctors in more effectively detecting lung transplant rejection.

Conversely, the forceps biopsy is the standard method currently used in hospitals. It is known for its safety and is commonly used for taking lung tissue samples. However, it can sometimes cause tissue damage called "crush artifact," which may complicate the interpretation of biopsy results.

Both methods have demonstrated safety, with no significant adverse events reported, making them suitable options for patients considering this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cryoprobe Biopsy method because it offers a novel approach to diagnosing lung transplant rejection. Unlike the standard forceps biopsy, which can cause crush artifacts, the cryoprobe technique uses rapid cooling to freeze and adhere tissue to the probe, resulting in more intact tissue samples. This method could lead to more accurate diagnoses, potentially improving patient outcomes by helping doctors make better-informed decisions.

What evidence suggests that these biopsy methods are effective for diagnosing lung transplant rejection?

This trial will compare the Cryoprobe Biopsy Method with the Forceps Biopsy Method for detecting lung transplant rejection. Research has shown that the 1.1 mm cryoprobe biopsy method surpasses traditional biopsy forceps in detecting lung transplant rejection. One study found that the cryoprobe method identified acute rejection in 100% of cases, while forceps did so in only 79% of cases. The cryoprobe also collects larger lung tissue samples, which are less likely to sustain damage during the process. This method aids in early detection of rejection, crucial for the health of lung transplant patients. The cryoprobe's ability to reduce tissue damage and improve sample quality makes it a promising tool for more effective diagnosis of lung transplant rejection. ^{1 3 6 7 8}

Who Is on the Research Team?

John Joerns

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9225122/

Transbronchial Cryobiopsy Compared to Forceps Biopsy for ... Acute cellular rejection (ACR) is detected in 27% of lung transplant recipients (LTRs) within the first year after LTx and is an important risk ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0954611125001234

Comparing the 1.1 mm cryoprobe versus flexible forceps ... 1.1 mm cryoprobe improves rejection detection in lung transplant surveillance. Cryoprobe biopsy provides larger lung allograft samples and minimizes crush ...

3. jhltonline.org jhltonline.org/article/S1053-2498(21)01094-9/fulltext

Prospective Study of Comparison between Transbronchial ... The diagnostic yield of acute rejection using cryobiopsy is 100% compared to 79% using biopsy forceps. The difference in proportion is 0.20 [95% C.I: 0,11-0,29, ...

4. jhltopen.org jhltopen.org/article/S2950-1334(25)00057-6/fulltext

Transbronchial cryobiopsy alone versus combined with ... This trial evaluates the clinical value of forceps and cryobiopsies versus cryobiopsies as a standalone diagnostic tool.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06824402

Cryoprobe Biopsy and Chronic Rejection in Lung ... It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2950133425000576

Transbronchial cryobiopsy alone versus combined with ... This trial evaluates the clinical value of forceps and cryobiopsies versus cryobiopsies as a standalone diagnostic tool.

7. resmedjournal.com resmedjournal.com/article/S0954-6111(25)00123-4/abstract

Comparing the 1.1 mm cryoprobe versus flexible forceps ... 1.1 mm cryoprobe improves rejection detection in lung transplant surveillance. · Cryoprobe biopsy provides larger lung allograft samples and minimizes crush ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0012369213601397

Cryoprobe Transbronchial Lung Biopsy in Patients After ... We present the safety profile and biopsy results from the first 21 procedures in a pilot study comparing CPBx to FTBBx in patients after lung transplantation.