Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06340178
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-01
First Post:
2024-03-25
Brief Title:
CT-guided Lung Biopsy Risk Optimization Method
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
CT-guided Lung Biopsy Risk Optimization Method - Effect of Fluid Application in the Pleural Cavity and the Gravitational Effect of Pleural Pressure
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BROM-I
Brief Summary:
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
Detailed Description:
Study participants with written consent and the percutaneous CT-guided lung biopsy already regularly indicated by the referring doctors eg 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 Inselspitals 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None