Defining a Technique for the Use of Cryogenic Catheters for Biopsy and Ablation for the Diagnostic and Treatment of Pulmonary Lesions: An Ex-Vivo Human Lung Model Study.

Study Overview
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Brief Summary
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Developing a standardized methodology for the use of novel cryogenic catheters for transbronchial cryobiopsy and cryoablation of pulmonary lesions.

Detailed Description
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Surgical lung biopsy (SLB) and surgical resection are the current gold standard for both tissue sampling and ablation of pulmonary lesions. Albeit the use of minimally invasive surgical techniques (VATS), these interventions are frequently associated with complications which include: prolonged air leak, pneumonia, prolonged length of stay in the intensive care unit as well as an increased mortality rate which is influenced by the nature (elective vs non-elective) of the case. To reduce trauma to patients, transbronchial interventions are becoming increasingly popular. However, current techniques have only been demonstrated in humans for lung biopsy and often provide lesser quality specimens than SLB. Promising results have been achieved using cryotechnology but a standardized technique has yet to be established. To demonstrate the potential for transbronchial interventions using cryo, we aim to develop a standardized technique for transbronchial cryobiopsy and cryoablation of pulmonary lesions using a human ex-vivo model.

Official Title
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Defining a Technique for the Use of Cryogenic Catheters for Biopsy and Ablation for the Diagnostic and Treatment of Pulmonary Lesions: An Ex-Vivo Human Lung Model Study.

Conditions
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Lung Diseases

Intervention / Treatment
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* Diagnostic Test: Cryo Ex Vivo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing lung transplant surgery Exclusion Criteria: Organ donor ineligible to donate lungs Healthy individuals

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ex Vivo Cryo<br>Multiple procedures will be performed to each model in order to accomplish the objectives of the study. Tissue samples will be taken from the models and images will be performed. This will allow us to determine which configuration is the optimal for obtaining the more effective and stable models that could offer the best quality specimens as well. | Diagnostic Test: Cryo Ex Vivo<br>* Lungs from patients undergoing lung transplantation after their removal from the recipient patient with previous informed consent signed before transplantation will be obtained. The organs will be placed in an acrylic box and will be kept at a temperature of 37 Celsius degrees. The lungs will be mechanically ventilated connected by an endotracheal tube size 8 inserted in the bronchus with the balloon inflated and a silk suture providing a hermetic closure proximal to the balloon. Tissue samples will be taken from the models and images will be performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of Pleural breakage (Absent or Present) | Develop a standardized methodology for the use of novel cryoprobes for transbronchial lung biopsies and ablation of pulmonary lesions | 48 months | 
| Temperature of ice ball at center; Temperature of ice ball at periphery; Temperature of ice ball at varying distances from ice ball | Develop a standardized methodology for the use of novel cryoprobes for transbronchial lung biopsies and ablation of pulmonary lesions | 48 months | 
| Model of cryogen | Develop a standardized methodology for the use of novel cryoprobes for transbronchial lung biopsies and ablation of pulmonary lesions | 48 months | 
| Freezing Time | Develop a standardized methodology for the use of novel cryoprobes for transbronchial lung biopsies and ablation of pulmonary lesions | 48 months | 
| Size of resected specimen | Develop a standardized methodology for the use of novel cryoprobes for transbronchial lung biopsies and ablation of pulmonary lesions | 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss and complication | Feasibility of transbronchial lung cryobiopsy and cryoablation | 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung, cryobiopsy, cryoablation, transbronchial intervention