CT-guided Lung Biopsy Risk Optimization Method (BROM-I)

CT-guided Lung Biopsy Risk Optimization Method - Effect of Fluid Application in the Pleural Cavity and the Gravitational Effect of Pleural Pressure

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.

Study Overview

• Status: Recruiting
• Conditions: Pneumothorax; Risk Factors; Biopsy, Needle; Radiology, Interventional
• Intervention / Treatment: Procedure: Fluid application during ct-guided lung biopsy

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 Type: Interventional
• Enrollment (Estimated): 198
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Brönnimann, MD; Phone Number: +41316326510; Email: michael.broennimann@insel.ch
• Study Contact Backup: Name: Johannes Heverhagen, Prof; Phone Number: +41316322648; Email: johannes.heverhagen@insel.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 10
    • Contact: Johannes Heverhagen, Prof; Phone Number: +41316322648; Email: johannes.heverhagen@insel.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fluid administration; Fluid is given in pleural or subpleural space during CT-guided lung biopsy.	Procedure: Fluid 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
No Intervention: No fluid administration; No additional fluid is given prior to the CT-guided lung biopsy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediate after biopsy, expected to be on average 5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with bleeding	Local bleeding in lung parenchyma	Immediate after biopsy, expected to be on average 5 minutes
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	Immediate after biopsy, expected to be on average 5 minutes
Number of patients with air embolism	Evidence of air embolism in the postprocedural CT image	Immediate after biopsy, expected to be on average 5 minutes

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Investigators: 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 record dates

Study Major Dates

• Study Start (Actual): September 29, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: March 25, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): April 1, 2024

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Biopsy; Risk Factors; Tomography; Pneumothorax; Image-Guided Biopsy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pneumothorax
• Other Study ID Numbers: 2024-00246

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data repository
• IPD Sharing Time Frame: After study closure
• IPD Sharing Access Criteria: Request to study P.I.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No