Lowering pneumothorax risk during CT-guided lung biopsy with small pleural fluid and targeted positioning
Official title: CT-guided Lung Biopsy Risk Optimization Method - Effect of Fluid Application in the Pleural Cavity and the Gravitational Effect of Pleural Pressure
Run by Insel Gruppe AG, University Hospital Bern · NCT06340178 · Data updated 2026-11-12
This study will see if injecting a small amount of fluid into the pleural space and positioning the patient so the biopsy site is gravity-dependent can lower the chance of a pneumothorax in adults having CT-guided percutaneous lung biopsy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 198 (estimated) |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Status | Recruiting |
| Started | September 29, 2025 |
| Main results expected | April 1, 2027 |
| Study ends | April 1, 2027 |
| Registry record updated | February 2, 2026 |
| Trial ID | NCT06340178 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 with an indeterminate or suspicious lung lesion for which a percutaneous CT-guided biopsy is clinically indicated, especially when transbronchial biopsy is unsuitable or has failed, are appropriate candidates.
✕Probably not a fit
Patients with preintervention bleeding into the pleural cavity, infiltration of the thoracic wall, pregnancy, or those needing biopsy of more than one lesion at the same time are excluded and unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled study enrolls adults already scheduled for a clinically indicated CT-guided percutaneous lung biopsy and randomizes them immediately before the procedure to receive either a small pleural fluid injection plus gravity-dependent positioning or standard care without fluid. Interventional radiologists obtain three samples using an 18G or 20G coaxial needle and manage any complications according to standard clinical practice. Imaging (DICOM), laboratory results, electronic medical record data, and pathology findings are collected from the hospital PACS, RIS, iPDOS®/KISS by Epic®, and the Institute of Pathology for analysis. The lung biopsy itself is only performed when clinically indicated and is not a study-specific procedure.
Why it matters
Potential benefit: If successful, the technique could reduce pneumothorax rates, decrease the need for chest tubes, and shorten recovery or hospital stays after CT-guided lung biopsy.
How similar studies have gone: Small technical reports and nonrandomized series have suggested pleural fluid injection and gravity positioning may reduce pneumothorax risk, but randomized evidence is still limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 10
Bern, Switzerland Recruiting
Study contacts
- Principal investigator: Michael Brönnimann, MD — Department of Diagnostic, Interventional and Paediatric Radiology, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 10, 3010 Bern, Switzerland;
- Study coordinator: Michael Brönnimann, MD
- Email: michael.broennimann@insel.ch
- Phone: +41316326510
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.