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

NCT05259293 | Completed

• 1 other identifier: 2021/625
• Study Type: observational
• Target: 243
• Locations: 3 countries
• Sites: 6

Brief Summary

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.

Conditions

Pneumothorax Iatrogenic Postprocedural

Keywords

interventional radiology, iatrogenic pneumothorax, transthoracic lung biopsy, pneumothorax rate, pneumothorax characteristics, patient management

Outcome Measures

Primary Outcomes (1)

• Annual incidence rate of pneumothorax related to transthoracic lung biopsy on total number of lung biopsies

  3 months

Secondary Outcomes (2)

• Annual incidence rate of hospitalisation in patients with pneumothorax related to lung biopsies

  3 months

• Annual incidence rate of drainage in patients with pneumothorax related to lung biopsies

  3 months

Interventions

No intervention - retrospective study OTHER

This is a retrospective study. No intervention.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (6)

CHU de Besançon

Besançon, France

Location

Institut Bergonié

Bordeaux, France

Location

CHU de Tours

Tours, France

Location

Institut Gustave Roussy

Villejuif, France

Location

Saint James Hospital

Dublin, Ireland

Location

Oxford University Hospitals

Oxford, United Kingdom

Location

Study Officials

• Julien BEHR, MD

  CHU de Besançon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: February 28, 2022
• Study Start: December 9, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 19, 2024

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); FR (4); IE (1)