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NCT Number: NCT06340178

CT-guided Lung Biopsy Risk Optimization Method

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 10

Bern, 3010, Switzerland

Location status: Recruiting

Location contact

Johannes Heverhagen, Prof

CONTACT

[email protected]

+41316322648

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluid application during ct-guided lung biopsy

Procedure

Injection of a small amount of fluid (max. 20 ml sodium chlorid) in the pleural cavity at the biopsy site

Primary outcomes

  1. 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

  1. Number of patients with bleeding

    Time frame: Immediate after biopsy, expected to be on average 5 minutes

    Local bleeding in lung parenchyma

  2. Number of patients with chest tube placement

    Time frame: Immediate after biopsy, expected to be on average 5 minutes

    Chest tube placement if pneumothorax is more than 2 cm immediate after biopsy or progressive pneumothorax over time

  3. Number of patients with air embolism

    Time frame: Immediate after biopsy, expected to be on average 5 minutes

    Evidence of air embolism in the postprocedural CT image

Study contacts

Contact information is provided by the study sponsor or research team.

Johannes Heverhagen, Prof

CONTACT

[email protected]

+41316322648

Michael Brönnimann, MD

CONTACT

[email protected]

+41316326510

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

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

Acronym: BROM-I

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 1, 2024
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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