Characteristics of Pneumothorax Associated With Transthoracic Percutaneous Lung Biopsy in Standard of Care (PNOrate)

February 18, 2022 updated by: Centre Hospitalier Universitaire de Besancon

Characteristics of Pneumothorax Associated With Transthoracic Percutaneous Lung Biopsy in Standard of Care: a Retrospective Study in 6 Centers

The number of lung biopsies has increased steadily in recent years. Pneumothorax is the most common complication of a lung biopsy and can occur during the procedure, immediately after the procedure or within a few hours (delayed pneumothorax). The incidence of pneumothorax in the literature is very different from one study to another: it has been reported to be from 9 to 54% in patients undergoing percutaneous transthoracic needle biopsy. This difference of incidence could be explained by the absence of consensus for the definition of an iatrogenic pneumothorax.

The characteristics of pneumothorax and the management of patients with iatrogenic pneumothorax will be evaluated in different centres in a retrospective manner. This study will contribute to refining the criteria for defining pneumothorax occurring during lung biopsy and will provide a better understanding of the condition and its management.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Besançon, France
        • Recruiting
        • CHU de Besancon
        • Contact:
        • Principal Investigator:
          • Julien BEHR, MD
      • Bordeaux, France
        • Recruiting
        • Institut Bergonié
        • Principal Investigator:
          • Jean Palussiere, MD
      • Tours, France
        • Recruiting
        • CHU de Tours
        • Principal Investigator:
          • Antoine BRAULT, MD
      • Villejuif, France
        • Recruiting
        • Institut Gustave Roussy
        • Principal Investigator:
          • Lambros Tselikas, MD
  • Ireland
      • Dublin, Ireland
        • Recruiting
        • Saint James Hospital
        • Principal Investigator:
          • Peter BEDDY, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients who presented with a pneumothorax following their lung biopsy (see eligibility criteria)

Description

Inclusion Criteria:

  • Patients aged 18 years old and more at the time of the biopsy procedure in year 2020
  • Having had a pneumothorax following their transthoracic percutaneous lung biopsy in year 2020

Exclusion Criteria:

  • Objection to the use of the data (French sites only)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Annual incidence rate of pneumothorax related to transthoracic lung biopsy on total number of lung biopsies
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Annual incidence rate of hospitalisation in patients with pneumothorax related to lung biopsies
Time Frame: 3 months
3 months
Annual incidence rate of drainage in patients with pneumothorax related to lung biopsies
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Julien BEHR, MD, CHU de Besancon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2021

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

December 7, 2021

First Submitted That Met QC Criteria

February 18, 2022

First Posted (Actual)

February 28, 2022

Study Record Updates

Last Update Posted (Actual)

February 28, 2022

Last Update Submitted That Met QC Criteria

February 18, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/625

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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