CT-guided Lung Biopsy Risk Optimization Method

Pneumothorax Clinical Trial

— BROM-I  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06340178
• Other study ID #: 2024-00246
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: April 1, 2027

Study information

• Verified date: March 2024
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Michael Brönnimann, MD
• Phone: +41316326510
• Email: michael.broennimann[@]insel.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 198
• Est. completion date: April 1, 2027
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Biopsy, Needle
• Pneumothorax
• Risk Factors

Intervention

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

Locations

Country	Name	City	State
Switzerland	Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 10	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of patients with bleeding	Local bleeding in lung parenchyma	Immediate after biopsy, expected to be on average 5 minutes
Secondary	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
Secondary	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