CT-guided Lung Biopsy Risk Optimization Method
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorInsel Gruppe AG, University Hospital Bern
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
Preintervention bleeding into the pleural cavity
More than 1 lesion should be biopsied at the same time
Infiltration of the thoracic wall
Pregnancy
Trial design
Design model
Parallel
Treatments tested in this trial
Fluid application during ct-guided lung biopsy
Procedure/SurgeryInjection of a small amount of fluid (max. 20 ml sodium chlorid) in the pleural cavity at the biopsy site
Treatment groups
198 Participants
are divided into 2 treatment groupsGroup A: Fluid administrationExperimental treatment 1 intervention
Group B: No fluid administrationNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Immediate after biopsy, expected to be on average 5 minutesSecondary outcomes
1
Number of patients with bleeding
Local bleeding in lung parenchyma
Time frame
Immediate after biopsy, expected to be on average 5 minutes2
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
Time frame
Immediate after biopsy, expected to be on average 5 minutes3
Number of patients with air embolism
Evidence of air embolism in the postprocedural CT image
Time frame
Immediate after biopsy, expected to be on average 5 minutesSponsors and contacts
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Source ClinicalTrials.gov