Cryoprobe Biopsy and Chronic Rejection in Lung Transplant Recipients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-17

Study Completion Date

2027-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lung Transplant Rejection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Caregivers

Allocation will not be known to either the patient or bronchoscopist until the intra-procedural randomization timepoint, after which blinding of the bronchoscopist is not possible due to the nature of the procedure.

Study Groups

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Cryoprobe Biopsy Method

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 Type EXPERIMENTAL

Cryoprobe Biopsy

Intervention Type DEVICE

3 transbronchial lung biopsies of two separate lobes will be obtained using a flexible cryoprobe: single-use, ø 1.1 mm (Erbe Elektromedizin GmbH, 20402-401) used with ERBECRYO 2 (Erbe Elektromedizin GmbH, 10402-000

Forceps Biopsy Method

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

Group Type ACTIVE_COMPARATOR

Forceps Biopsy

Intervention Type DEVICE

10-12 transbronchial lung biopsies will be obtained using standard of care biopsy forceps: Olympus disposable EndoJaw (FB-211), Olympus, USA

Interventions

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Forceps Biopsy

10-12 transbronchial lung biopsies will be obtained using standard of care biopsy forceps: Olympus disposable EndoJaw (FB-211), Olympus, USA

Intervention Type DEVICE

Cryoprobe Biopsy

3 transbronchial lung biopsies of two separate lobes will be obtained using a flexible cryoprobe: single-use, ø 1.1 mm (Erbe Elektromedizin GmbH, 20402-401) used with ERBECRYO 2 (Erbe Elektromedizin GmbH, 10402-000

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No