Cryoprobe Biopsy and Chronic Rejection in Lung Transplant Recipients

Mayo Clinic

Status: Enrolling

Conditions: Lung Transplant Rejection

Treatments: Device: Forceps Biopsy; Device: Cryoprobe Biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT06824402

23-011339

Details and patient eligibility

About

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.

Full description

The purpose of this 1:1 randomized clinical trial is to compare the histological quality and diagnostic yield of tissue samples acquired using a 1.1 mm cryoprobe with those obtained with biopsy forceps in lung transplant recipients for graft surveillance.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Male and female lung transplant recipients age >18 at the time of informed consent
• Patients clinically meet indication for post-transplant lung biopsy or planned routine surveillance and have been scheduled for bronchoscopy with transbronchial biopsy.
• Be willing and able to sign the informed consent.

Exclusion Criteria

• Patients with known bleeding diathesis
• Platelet count <50,000 per μL within 14 days of the biopsy procedure
• Current use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended amount of time prior to an invasive procedure (aspirin monotherapy is acceptable)
• Inability or unwillingness to give informed consent or study procedures
• Pregnant or nursing females, or females who intend to become pregnant
• Females of child-bearing potential who decline a pregnancy test prior to enrollment
• If an investigator does not feel that this study is in the subject's best interest or would be a good fit for the study.
• International Normalized Ratio (INR) >1.5
• Do Not Resuscitate (DNR) status
• Do Not Intubate (DNI) status
• Single lung transplant recipients

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Cryoprobe Biopsy Method

Experimental group

Description:

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.

Treatment:

Device: Cryoprobe Biopsy

Forceps Biopsy Method

Active Comparator group

Description:

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

Treatment:

Device: Forceps Biopsy