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Cryoprobe Biopsy and Chronic Rejection in Lung Transplant Recipients

ConditionLung Transplant Rejection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorMayo Clinic

About 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 does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Forceps Biopsy

    Device

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

  • Cryoprobe Biopsy

    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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Cryoprobe Biopsy MethodExperimental treatment 1 intervention
Group B: Forceps Biopsy MethodActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Quality and diagnostic yield of tissue samples

Histological accessibility grade is determined by the pathologist according to the Lung Allograft Standard Histological Analysis (LASHA) scale and the 2007 Revision of the 1996 working formulation for the Standardization of Nomenclature in the Diagnosis of Lung Rejection, published by the ISHLT.

Time frame
Baseline

Secondary outcomes

1

Time duration

Duration of each individual biopsy procedure from insertion of the bronchoscope after airway has been secured until bronchoscope is withdrawn. .

Time frame
Baseline
2

Tissue sample adequacy

Number of biopsy samples that are adequate to determine rejection based on the presence of well expanded alveoli, as determined by the pathologist.

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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