Clinical trial NCT06340178: CT-guided Lung Biopsy Risk Optimization Method
Official title: CT-guided Lung Biopsy Risk Optimization Method - Effect of Fluid Application in the Pleural Cavity and the Gravitational Effect of Pleural Pressure
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pneumothorax
Biopsy, Needle
Risk Factors
Radiology, Interventional
Keywords: Image-Guided Biopsy
Risk Factors
Tomography
Biopsy
Pneumothorax
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with pneumothorax
timeFrame: Immediate after biopsy, expected to be on average 5 minutes
Secondary outcomes:
measure: Number of patients with bleeding
timeFrame: Immediate after biopsy, expected to be on average 5 minutes
measure: Number of patients with chest tube placement
timeFrame: Immediate after biopsy, expected to be on average 5 minutes
measure: Number of patients with air embolism
timeFrame: Immediate after biopsy, expected to be on average 5 minutes
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 10
Study officials:
affiliation: Department of Diagnostic, Interventional and Paediatric Radiology, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 10, 3010 Bern, Switzerland;
name: Michael Brönnimann, MD
role: PRINCIPAL_INVESTIGATOR
References: