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

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

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.

Trial contacts and locations

0

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Central trial contact

Michael Brönnimann, MD; Johannes Heverhagen, Prof

Data sourced from clinicaltrials.gov

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