Three-Dimensional Fluoroscopic Guidance During Transbronchial Cryobiopsy

Completed

Interventions: Other: Electronic Health Record Review
Procedure: Transbronchial Cryobiopsy Guided by Three-Dimensional Fluoroscopy

Brief 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.

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Observational (transbronchial cryobiopsy)	Electronic Health Record Review	Patients undergo transbronchial cryobiopsy guided by three-dimensional fluoroscopy. Patients' medical records are also reviewed.
Observational (transbronchial cryobiopsy)	Transbronchial Cryobiopsy Guided by Three-Dimensional Fluoroscopy	Patients undergo transbronchial cryobiopsy guided by three-dimensional fluoroscopy. Patients' medical records are also reviewed.

Primary Outcome Measures

Name	Time	Method
Incidence of pneumothorax	Up to 72 hours after cryobiopsy	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.

Secondary Outcome Measures

Name	Time	Method

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