Actively Recruiting
CT-guided Lung Biopsy Risk Optimization Method Effect of Fluid Application in the Pleural Cavity and the Gravitational Effect of Pleural Pressure
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2026-02-02
198
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether injecting a small amount of fluid into the pleural cavity during a CT-guided lung biopsy can reduce the risk of pneumothorax, a common complication. This randomized controlled study focuses on patients who need a lung biopsy due to suspicious or unclear lung lesions and aims to improve biopsy safety by also considering patient positioning to biopsy gravity-dependent lung areas. Participants in this study will be randomly assigned to receive either an injection of up to 20 ml of sodium chloride fluid into the pleural cavity before biopsy or no fluid. The biopsy procedure involves taking three samples using an 18G or 20G coaxial needle, performed by Interventional Radiology. The biopsy itself is clinically indicated and not specifically for the study. Data, including images, lab results, clinical information, and pathology findings, will be collected and analyzed. During the study, researchers will monitor patients immediately after biopsy for complications such as pneumothorax, bleeding, chest tube placement, and air embolism, typically within about five minutes. Records and imaging from hospital systems will be reviewed for analysis. Participation involves the biopsy procedure as part of usual care, with additional data collection to assess risks. The study is planned to run until April 2027.
CONDITIONS
Brief Title
CT-guided Lung Biopsy Risk Optimization Method
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to provide informed consent and be over 18 years old
- Have an indeterminate or suspicious lung lesion unsuitable for transbronchial biopsy or after an unsuccessful transbronchial biopsy
- Have a biopsy indication given by a referring specialist
You will not qualify if you...
- Bleeding into the pleural cavity before the biopsy
- More than one lesion to be biopsied at the same time
- Infiltration of the thoracic wall
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single day
Participants undergo a CT-guided lung biopsy with or without fluid administration in the pleural cavity as part of the procedure.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 10
Bern, Switzerland, 3010
Actively Recruiting
Research Team
M
Michael Brönnimann, MD
J
Johannes Heverhagen, Prof
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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