Cryoprobe Transbronchial Lung Biopsy in Lung Transplant Patients

Study Overview
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Brief Summary
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Lung transplant recipients undergo bronchoscopy with biopsies for clinical indications and for surveillance in the diagnosis of acute rejection using standard transbronchial forceps. It is recognized that standard forceps biopsies underestimate the presence or degree of airway rejection due to crush artifact and sample size. Transbronchial cryobiopsies have been shown in the literature to provide larger samples without crush artifact in a safe fashion in lung cancer patients. The aim of this study is to determine if transbronchial cryobiopsy is superior to standard transbronchial forceps biopsies in regards to sample size, architecture and the diagnosis of early rejection in lung transplant recipients which if discovered earlier may improve survival.

Official Title
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Prospective Controlled Study of Transbronchial Cryoprobe Versus Forceps Biopsy for Acute Rejection in Lung Transplantation

Conditions
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Lung Transplantation

Intervention / Treatment
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* Procedure: Cryoprobe biopsy
* Procedure: Forceps Biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals referred for either clinically indicated or surveillance flexible bronchoscopy will be included in the study population Age greater than 18 years and having undergone bilateral orthotopic lung transplantation Exclusion Criteria: Coagulopathy: plts < 50,000 international normalized ratio (INR) > 1.5 Forced expiratory volume at one second (FEV1) < 0.8 Diffuse bullous disease Hemodynamic instability Severe hypoxemia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cryoprobe biopsy<br>All patients enrolled will undergo standard forceps biopsies followed by cryoprobe biopsies and results will be compared | Procedure: Cryoprobe biopsy<br> <br> |
| Active Comparator: Forceps Biopsy<br>All patients enrolled will undergo standard forceps biopsies followed by cryoprobe biopsies and results will be compared | Procedure: Forceps Biopsy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in size of biopsy specimen and architectural preservation of the airways/alveoli (ie degree of crush artifact) | Direct measurements of pathologic specimens from the forceps and cryoprobe will be compared. In addition, amount of crush artifact will alse be directly measured and compared utilizing pathology software which measures area of viable tissue. | From date of study enrollment until the patient is 2 years post lung transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield (ie presence of acute cellular rejections (ACR), chronic rejection, lymphocytic bronchiolitis and infection) | Each specimen will be independently reviewed by a lung transplant pathology physician to determine the presence or absence of rejection and results compared. All data will be available to the transplant team in the event any rejection is found, it will be acted upon immediately as per the transplant teams protocol. | From date of study enrollment until the patient is 2 years post lung transplant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Transplantation, Acute Rejection