Pneumothorax Iatrogenic PostproceduralPNOrateNCT05259293
Characteristics of Pneumothorax Associated With Transthoracic Percutaneous Lung Biopsy in Standard of Care
An observational study of Pneumothorax Iatrogenic Postprocedural, run by Centre Hospitalier Universitaire de Besancon at 6 sites in 3 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumothorax Iatrogenic Postprocedural
- How many people
- 243 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 9 Dec 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who presented with a pneumothorax following their lung biopsy (see eligibility criteria)
Who may be able to join
- 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
Who cannot join
- Objection to the use of the data (French sites only)
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
France4 sites
CHU de Besançon
Besançon
Institut Bergonié
Bordeaux
CHU de Tours
Tours
Institut Gustave Roussy
Villejuif
About this study
Official title: 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.
- Conditions
- Pneumothorax Iatrogenic Postprocedural
- Being tested
- No intervention - retrospective study
- Keywords
- interventional radiology, iatrogenic pneumothorax, transthoracic lung biopsy, pneumothorax rate, pneumothorax characteristics, patient management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention - retrospective studyOther
This is a retrospective study. No intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual incidence rate of pneumothorax related to transthoracic lung biopsy on total number of lung biopsies
Measured: 3 months
Secondary outcomes (2)
Annual incidence rate of hospitalisation in patients with pneumothorax related to lung biopsies
Measured: 3 months
Annual incidence rate of drainage in patients with pneumothorax related to lung biopsies
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start9 Dec 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumothorax Iatrogenic PostproceduralStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien BEHR, MD, Principal investigator, CHU de Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259293
- Sponsor's protocol ID
- 2021/625
- Acronym
- PNOrate
- Status last verified
- Jan 2023
- First submitted
- 7 Dec 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Pneumothorax Associated With Transthoracic Percutaneous Lung Biopsy in Standard of Care: a Retrospective Study in 6 Centers
- ClinicalTrials.gov ID
- NCT05259293
- Acronym / sponsor ID
- PNOrate / 2021/625
- Conditions
- Pneumothorax Iatrogenic Postprocedural
- Keywords
- interventional radiology, iatrogenic pneumothorax, transthoracic lung biopsy, pneumothorax rate, pneumothorax characteristics, patient management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 28 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who presented with a pneumothorax following their lung biopsy (see eligibility criteria)
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Objection to the use of the data (French sites only)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention - retrospective studyThis is a retrospective study. No intervention. | Other | – |
Primary outcome
Annual incidence rate of pneumothorax related to transthoracic lung biopsy on total number of lung biopsies
Time frame: 3 months
2 secondary outcomes
Annual incidence rate of hospitalisation in patients with pneumothorax related to lung biopsies
Time frame: 3 months
Annual incidence rate of drainage in patients with pneumothorax related to lung biopsies
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Pneumothorax Iatrogenic Postprocedural
Not yet recruitingObservational study
Clinical Value of Routine Chest Radiography and Point-of-Care Lung Ultrasound Following Ambulatory Thoracic Sympathectomy
Pneumothorax Iatrogenic Postprocedural
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julien BEHR, MD principal investigator
CHU de Besançon
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumothorax Iatrogenic Postprocedural, run by Centre Hospitalier Universitaire de Besancon at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France, Ireland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual incidence rate of pneumothorax related to transthoracic lung biopsy on total number of lung biopsies (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.