Three-Dimensional Fluoroscopic Guidance During Transbronchial Cryobiopsy

Study Overview
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Brief Summary
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This study assesses the effectiveness of transbronchial cryobiopsy guided by 3-dimensional fluoroscopy. Transbronchial cryobiopsy is a procedure to collect lung tissue. The main side effect seen after a transbronchial cryobiopsy is pneumothorax (air leaking out of the lung, which may cause a completely or partially collapsed lung). The standard imaging scans used during this procedure are 2-dimensional (like a photo), which can make it difficult for the doctor to know exactly where the biopsy tool is during the procedure. If the exact location of the device is not clear, a patient can be at a higher risk of pneumothorax. Using a 3-dimensional imaging technique may help to decrease the risk of pneumothorax during transbronchial cryobiopsy.

Detailed Description
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PRIMARY OBJECTIVE: I. To determine if transbronchial cryobiopsy guided by three-dimensional fluoroscopy reduces the incidence of pneumothorax up to 72 hours after transbronchial cryobiopsy. SECONDARY OBJECTIVE: I. To describe outcomes of cryobiopsy, need for interventions related to transbronchial cryobiopsy, radiation dose, and any complications or adverse events after transbronchial cryobiopsy guided by three-dimensional fluoroscopy. OUTLINE: Patients undergo transbronchial cryobiopsy guided by three-dimensional fluoroscopy. Patients' medical records are also reviewed.

Official Title
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Three-Dimensional Fluoroscopic Guidance During Transbronchial Cryobiopsy, a Prospective Pilot Study

Conditions
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Lung Carcinoma

Intervention / Treatment
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* Other: Electronic Health Record Review
* Procedure: Transbronchial Cryobiopsy Guided by Three-Dimensional Fluoroscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Presence of an intraparenchymal lung lesion for which cryobiopsy is deemed the most appropriate method of biopsy Ability to provide informed consent Exclusion Criteria: Acute respiratory failure (defined as oxygen requirement > 4 L/min by nasal cannula above baseline, or need for any intervention to support ventilation and/or gas exchange for any duration, including invasive and non-invasive positive pressure ventilation, high-flow therapy, non-rebreather mask, or Venturi mask) Intensive care unit (ICU) admission Forced vital capacity (FVC) < 50% or diffusing capacity of the lung for carbon monoxide (CO) (DLCO) < 35% (if pulmonary function tests are available) Known or suspected pulmonary hypertension (defined as elevated right ventricular systolic pressure on echocardiogram, if available) Acute renal failure or chronic kidney disease Platelets < 100,000/uL International normalized ratio (INR) > 1.5 Use of anticoagulant therapy that cannot be held for 2 days Use of antiplatelet therapy (other than baby aspirin) that cannot be held for 5 days Any bleeding diathesis Pregnancy

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (transbronchial cryobiopsy)<br>Patients undergo transbronchial cryobiopsy guided by three-dimensional fluoroscopy. Patients' medical records are also reviewed. | Other: Electronic Health Record Review<br>* Review of medical records<br>Procedure: Transbronchial Cryobiopsy Guided by Three-Dimensional Fluoroscopy<br>* Undergo transbronchial cryobiopsy guided by three-dimensional fluoroscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of pneumothorax | The proportion of patients developing pneumothorax will be compared with the proportion in the historical control (i.e., 20%) using two-sided binomial test. A p-value of less than 0.05 will indicate a statistical significance. The proportion of patients identified as developing pneumothorax and its exact 95% confidence interval will be estimated. Poisson regression model will be used to estimate the incidence of pneumothorax accounting for the number of biopsy sites. | Up to 72 hours after cryobiopsy |