CT-guided Lung Biopsy Risk Optimization Method

Not Applicable

Not yet recruiting

• Conditions: Biopsy, Needle; Risk Factors; Radiology, Interventional; Pneumothorax
• Interventions: Procedure: Fluid application during ct-guided lung biopsy

• Registration Number: NCT06340178
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Study Timeline

• Study First Submitted: 2024-03-25
• Study First Submitted QC: 2024-03-25
• Study First Posted: 2024-04-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-20
• Study Start: 2025-04-01
• Primary Completion: 2026-04-01
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 198

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluid administration	Fluid application during ct-guided lung biopsy	Fluid is given in pleural or subpleural space during CT-guided lung biopsy.

Primary Outcome Measures

Name	Time	Method
Number of patients with pneumothorax	Immediate after biopsy, expected to be on average 5 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Number of patients with air embolism	Immediate after biopsy, expected to be on average 5 minutes	Evidence of air embolism in the postprocedural CT image
Number of patients with chest tube placement	Immediate after biopsy, expected to be on average 5 minutes	Chest tube placement if pneumothorax is more than 2 cm immediate after biopsy or progressive pneumothorax over time
Number of patients with bleeding	Immediate after biopsy, expected to be on average 5 minutes	Local bleeding in lung parenchyma

Trial Locations

Locations (1)

Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 10; 🇨🇭 Bern, Switzerland