CT-guided Lung Biopsy Risk Optimization Method
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fluid application during ct-guided lung biopsy.
- Who it may be relevant to
- Registry conditions: Pneumothorax, Biopsy, Needle, Risk Factors, Radiology, Interventional. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
CT-guided Lung Biopsy Risk Optimization Method - Effect of Fluid Application in the Pleural Cavity and the Gravitational Effect of Pleural Pressure
Overview
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.
Interventions
- 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
Primary outcome measures
- Number of patients with pneumothorax [Time frame: Immediate after biopsy, expected to be on average 5 minutes]
Secondary outcome measures (3)
- Number of patients with bleeding [Time frame: Immediate after biopsy, expected to be on average 5 minutes]
- Number of patients with chest tube placement [Time frame: Immediate after biopsy, expected to be on average 5 minutes]
- Number of patients with air embolism [Time frame: Immediate after biopsy, expected to be on average 5 minutes]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Switzerland · 1 center
- Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 10 — Bern
Identifiers
NCT: NCT06340178 · 2024-00246