Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 10
Bern, 3010, Switzerland
Location status: Recruiting
NCT Number: NCT06340178
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.
Interested in participating?
Request Info18 year–100 year
All sexes
Interventional
Not applicable
Bern, 3010, Switzerland
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Injection of a small amount of fluid (max. 20 ml sodium chlorid) in the pleural cavity at the biopsy site
Time frame: Immediate after biopsy, expected to be on average 5 minutes
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.
Time frame: Immediate after biopsy, expected to be on average 5 minutes
Local bleeding in lung parenchyma
Time frame: Immediate after biopsy, expected to be on average 5 minutes
Chest tube placement if pneumothorax is more than 2 cm immediate after biopsy or progressive pneumothorax over time
Time frame: Immediate after biopsy, expected to be on average 5 minutes
Evidence of air embolism in the postprocedural CT image
Contact information is provided by the study sponsor or research team.
Johannes Heverhagen, Prof
CONTACT
Michael Brönnimann, MD
CONTACT
Insel Gruppe AG, University Hospital Bern
Other
CT-guided Lung Biopsy Risk Optimization Method - Effect of Fluid Application in the Pleural Cavity and the Gravitational Effect of Pleural Pressure
Acronym: BROM-I
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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