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CT-guided Lung Biopsy Risk Optimization Method

NCT ID: NCT06340178

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2027-04-01

Brief Summary

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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

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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.

Conditions

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Pneumothorax Biopsy, Needle Risk Factors Radiology, Interventional

Keywords

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Image-Guided Biopsy Risk Factors Tomography Biopsy Pneumothorax

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Fluid administration

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

Group Type EXPERIMENTAL

Fluid application during ct-guided lung biopsy

Intervention Type PROCEDURE

Injection of a small amount of fluid (max. 20 ml sodium chlorid) in the pleural cavity at the biopsy site

No fluid administration

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Brönnimann, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Diagnostic, Interventional and Paediatric Radiology, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 10, 3010 Bern, Switzerland;

Locations

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Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 10

Bern, , Switzerland

Site Status

Countries

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Switzerland

Central Contacts

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Michael Brönnimann, MD

Role: CONTACT

Phone: +41316326510

Email: [email protected]

Johannes Heverhagen, Prof

Role: CONTACT

Phone: +41316322648

Email: [email protected]

Other Identifiers

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2024-00246

Identifier Type: -

Identifier Source: org_study_id