Lung Cancer Clinical Trial
Three-Dimensional Fluoroscopic Guidance During Transbronchial Cryobiopsy
Summary
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.
Full Description
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.
Eligibility Criteria
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
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There is 1 Location for this study
Houston Texas, 77030, United States More Info
Principal Investigator
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