Lung Carcinoma
Conditions
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.
Interventions
OTHERElectronic Health Record Review
Review of medical records
PROCEDURETransbronchial Cryobiopsy Guided by Three-Dimensional Fluoroscopy
Undergo transbronchial cryobiopsy guided by three-dimensional fluoroscopy
Sponsors
M.D. Anderson Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed