CT-guided Lung Biopsy Risk Optimization Method

NCT06340178 | Recruiting DMC

• 1 other identifier: 2024-00246
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumothorax; Biopsy, Needle; Risk Factors; Radiology, Interventional

Keywords

Image-Guided Biopsy; Risk Factors; Tomography; Biopsy; Pneumothorax

Outcome Measures

Primary Outcomes (1)

• Number of patients with pneumothorax

  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.

  Immediate after biopsy, expected to be on average 5 minutes

Secondary Outcomes (3)

• Number of patients with bleeding

  Immediate after biopsy, expected to be on average 5 minutes

• Number of patients with chest tube placement

  Immediate after biopsy, expected to be on average 5 minutes

• Number of patients with air embolism

  Immediate after biopsy, expected to be on average 5 minutes

Study Arms (2)

Fluid administration

EXPERIMENTAL

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

Procedure: Fluid application during ct-guided lung biopsy

No fluid administration

NO INTERVENTION

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

Interventions

Fluid application during ct-guided lung biopsy PROCEDURE

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

Fluid administration

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Preintervention bleeding into the pleural cavity
• More than 1 lesion should be biopsied at the same time
• Infiltration of the thoracic wall
• Pregnancy

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

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

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Pneumothorax

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Michael Brönnimann, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Brönnimann, MD

CONTACT

+41316326510; michael.broennimann@insel.ch

Johannes Heverhagen, Prof

CONTACT

+41316322648; johannes.heverhagen@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: September 29, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After study closure
• Access Criteria: Request to study P.I.

Locations

CH (1)