CT-guided Lung Biopsy Risk Optimization Method - Effect of Fluid Application in the Pleural Cavity and the Gravitational Effect of Pleural Pressure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 198
- Locations
- 1
- Primary Endpoint
- Number of patients with pneumothorax
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Fluid administration
Fluid is given in pleural or subpleural space during CT-guided lung biopsy.
Intervention: Fluid application during ct-guided lung biopsy (Procedure)
No fluid administration
No additional fluid is given prior to the CT-guided lung biopsy.
Outcomes
Primary Outcomes
Number of patients with pneumothorax
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.
Secondary Outcomes
- Number of patients with air embolism(Immediate after biopsy, expected to be on average 5 minutes)
- Number of patients with chest tube placement(Immediate after biopsy, expected to be on average 5 minutes)
- Number of patients with bleeding(Immediate after biopsy, expected to be on average 5 minutes)