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

Pneumothorax Iatrogenic Postprocedural Clinical Trial

— PNOrate  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05259293
• Other study ID #: 2021/625
• Status: Recruiting
• Start date: December 9, 2021
• Est. completion date: March 2022

Study information

• Verified date: February 2022
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Candice HOUG
• Phone: 0381218341
• Email: choug[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pneumothorax
• Pneumothorax Iatrogenic Postprocedural

Intervention

Other:
• No intervention - retrospective study
This is a retrospective study. No intervention.

Locations

Country	Name	City	State
France	CHU de Besançon	Besançon
France	Institut Bergonié	Bordeaux
France	CHU de Tours	Tours
France	Institut Gustave Roussy	Villejuif
Ireland	Saint James Hospital	Dublin

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon	Institut National de la Santé Et de la Recherche Médicale, France

Countries where clinical trial is conducted

France,  Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annual incidence rate of pneumothorax related to transthoracic lung biopsy on total number of lung biopsies		3 months
Secondary	Annual incidence rate of hospitalisation in patients with pneumothorax related to lung biopsies		3 months
Secondary	Annual incidence rate of drainage in patients with pneumothorax related to lung biopsies		3 months