Biopsy, Needle, Pneumothorax, Radiology, Interventional, Risk Factors
Conditions
Keywords
Image-Guided Biopsy, Risk Factors, Tomography, Biopsy, Pneumothorax
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 (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.
Interventions
PROCEDUREFluid application during ct-guided lung biopsy
Injection of a small amount of fluid (max. 20 ml sodium chlorid) in the pleural cavity at the biopsy site
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Ability to provide informed consent (knowledge of project languages), \>18 years. * Indeterminate or suspicious lung lesion unsuitable for transbronchial biopsy or Status after unsuccessful transbronchial biopsy * Indication for biopsy given by referring specialist (in patients).
Exclusion criteria
* Preintervention bleeding into the pleural cavity * More than 1 lesion should be biopsied at the same time * Infiltration of the thoracic wall * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with pneumothorax | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with bleeding | Immediate after biopsy, expected to be on average 5 minutes | Local bleeding in lung parenchyma |
| Number of patients with chest tube placement | 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 |
| Number of patients with air embolism | Immediate after biopsy, expected to be on average 5 minutes | Evidence of air embolism in the postprocedural CT image |
Countries
Switzerland
Contacts
CONTACTMichael Brönnimann, MD
CONTACTJohannes Heverhagen, Prof
PRINCIPAL_INVESTIGATORMichael Brönnimann, MD
Department of Diagnostic, Interventional and Paediatric Radiology, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 10, 3010 Bern, Switzerland;
Outcome results
None listed