Clinical trial NCT06824402: Cryoprobe Biopsy and Chronic Rejection in Lung Transplant Recipients
Official title: A Prospective, Randomized Clinical Trial to Evaluate the Feasibility of Miniature Cryoprobe Biopsy to Detect Acute and Chronic Lung Transplant Rejection in Lung Transplant Recipients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Transplant Rejection
Keywords: Lung Transplant
Bronchoscopy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria

* Male and female lung transplant recipients age \&gt;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 \&lt;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) \&gt;1.5
* Do Not Resuscitate (DNR) status
* Do Not Intubate (DNI) status
* Single lung transplant recipients

Primary outcomes:
measure: Quality and diagnostic yield of tissue samples
timeFrame: Baseline
Secondary outcomes:
measure: Time duration
timeFrame: Baseline
measure: Tissue sample adequacy
timeFrame: Baseline
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: John Joerns
role: PRINCIPAL_INVESTIGATOR
References: