Cryoprobe vs Forceps Biopsy for Lung Transplant Rejection

Recruiting in Palo Alto (17 mi)

Overseen ByJohn Joerns

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Trial Summary

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.

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

I am over 18 and have received a lung transplant.

I am scheduled for a lung biopsy after a transplant.

Exclusion Criteria

I have a bleeding disorder.

I am a woman able to have children but refuse to take a pregnancy test before joining.

I have received a lung transplant in one lung.

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: Cryoprobe Biopsy MethodExperimental Treatment1 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 MethodActive Control1 Intervention

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