Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
All Genders
Healthy Volunteers
ID06340178

CT-guided Lung Biopsy Risk Optimization Method Effect of Fluid Application in the Pleural Cavity and the Gravitational Effect of Pleural Pressure

Led by Insel Gruppe AG, University Hospital Bern · Updated on 2026-02-02

198

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying whether injecting a small amount of fluid into the pleural cavity during a CT-guided lung biopsy can reduce the risk of pneumothorax, a common complication. This randomized controlled study focuses on patients who need a lung biopsy due to suspicious or unclear lung lesions and aims to improve biopsy safety by also considering patient positioning to biopsy gravity-dependent lung areas. Participants in this study will be randomly assigned to receive either an injection of up to 20 ml of sodium chloride fluid into the pleural cavity before biopsy or no fluid. The biopsy procedure involves taking three samples using an 18G or 20G coaxial needle, performed by Interventional Radiology. The biopsy itself is clinically indicated and not specifically for the study. Data, including images, lab results, clinical information, and pathology findings, will be collected and analyzed. During the study, researchers will monitor patients immediately after biopsy for complications such as pneumothorax, bleeding, chest tube placement, and air embolism, typically within about five minutes. Records and imaging from hospital systems will be reviewed for analysis. Participation involves the biopsy procedure as part of usual care, with additional data collection to assess risks. The study is planned to run until April 2027.

CONDITIONS

Brief Title

CT-guided Lung Biopsy Risk Optimization Method

Who Can Participate

Age: 18Years - 100Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to provide informed consent and be over 18 years old
  • Have an indeterminate or suspicious lung lesion unsuitable for transbronchial biopsy or after an unsuccessful transbronchial biopsy
  • Have a biopsy indication given by a referring specialist
Not Eligible

You will not qualify if you...

  • Bleeding into the pleural cavity before the biopsy
  • More than one lesion to be biopsied at the same time
  • Infiltration of the thoracic wall
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Single day

Participants undergo a CT-guided lung biopsy with or without fluid administration in the pleural cavity as part of the procedure.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

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

Bern, Switzerland, 3010

Actively Recruiting

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Research Team

M

Michael Brönnimann, MD

J

Johannes Heverhagen, Prof

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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