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The purpose of this randomized controlled study is to evaluate the extent to which injection of a small amount of fluid in the pleural cavity at the biopsy site may reduce the risk of pneumothoraces, in addition to patient positioning to allow biopsy in gravity-dependent areas of the lung.
Study participants with written consent and the percutaneous, CT-guided lung biopsy already regularly indicated by the referring doctors (e.g., oncology) will be part of this study and will be randomized directly before the intervention. After randomization, the intervention is performed by Interventional Radiology, either with or without prior fluid administration into the pleural space. Three samples are taken using either an 18G or 20G coaxial needle, and any complications are treated according to the clinical standard. The lung biopsy will be only performed if clinically indicated and is not a study-specific intervention; data about the lung biopsy, like internal DICOM images of them retrieved from Inselspital's Picture Archiving and Communication System (PACS), laboratory results, and clinical information are retrieved from RIS (radiological information system) and iPDOS® and KISS by Epic® (electronic medical record) and the associated histopathological findings from the Institute of Pathology, University of Bern, will be analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluid administration | Experimental | Fluid is given in pleural or subpleural space during CT-guided lung biopsy. |
|
| No fluid administration | No Intervention | No additional fluid is given prior to the CT-guided lung biopsy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluid application during ct-guided lung biopsy | Procedure | Injection of a small amount of fluid (max. 20 ml sodium chlorid) in the pleural cavity at the biopsy site |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with pneumothorax | Reduction of pneumothorax occurrence in patients with biopsy in dependent lung areas and pleural fluid administration compared to patients with biopsy in dependent lung areas without fluid administration. Immediately after the lung biopsy, the final CT scan of the intervention is used to check whether a pneumothorax is present or not - i.e. whether there is new air in the pleural cavity. | Immediate after biopsy, expected to be on average 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with bleeding | Local bleeding in lung parenchyma | Immediate after biopsy, expected to be on average 5 minutes |
| Number of patients with chest tube placement | Chest tube placement if pneumothorax is more than 2 cm immediate after biopsy or progressive pneumothorax over time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Brönnimann, MD | Contact | +41316326510 | michael.broennimann@insel.ch | |
| Johannes Heverhagen, Prof | Contact | +41316322648 | johannes.heverhagen@insel.ch |
| Name | Affiliation | Role |
|---|---|---|
| Michael Brönnimann, MD | Department of Diagnostic, Interventional and Paediatric Radiology, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 10, 3010 Bern, Switzerland; | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 10 | Recruiting | Bern | 3010 | Switzerland |
Data repository
After study closure
Request to study P.I.
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| ID | Term |
|---|---|
| D011030 | Pneumothorax |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
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| Immediate after biopsy, expected to be on average 5 minutes |
| Number of patients with air embolism | Evidence of air embolism in the postprocedural CT image | Immediate after biopsy, expected to be on average 5 minutes |