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

Insel Gruppe AG, University Hospital Bern

Status: Not yet enrolling

Conditions: Biopsy, Needle; Pneumothorax; Risk Factors; Radiology, Interventional

Treatments: Procedure: Fluid application during ct-guided lung biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT06340178

2024-00246

Details and patient eligibility

About

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.

Full 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.

Enrollment: 198 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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198 participants in 2 patient groups

Fluid administration

Experimental group

Description:

Fluid is given in pleural or subpleural space during CT-guided lung biopsy.

Treatment:

Procedure: Fluid application during ct-guided lung biopsy

No fluid administration

No Intervention group

Description:

No additional fluid is given prior to the CT-guided lung biopsy.