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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-08947 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2020-1174 | Other Identifier | M D Anderson Cancer Center |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (transbronchial cryobiopsy) | Patients undergo transbronchial cryobiopsy guided by three-dimensional fluoroscopy. Patients' medical records are also reviewed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic Health Record Review | Other | Review of medical records |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with presence of an intraparenchymal lung lesion for which cryobiopsy is deemed the most appropriate method of biopsy
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| Name | Affiliation | Role |
|---|---|---|
| Bruce F Sabath | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Transbronchial Cryobiopsy Guided by Three-Dimensional Fluoroscopy | Procedure | Undergo transbronchial cryobiopsy guided by three-dimensional fluoroscopy |
|
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |