PneumothoraxSPOTNCT03488043
Predictive Score of PneumOThorax Secondary to CT-guided Transthoracic Lung Biopsy Made From a Large Retrospective Cohort and Validated on a Prospective Cohort
An observational study of Pneumothorax, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Transthoracic lung biopsy (TLB) provides a histological diagnosis of nodule or lung mass. Pneumothorax is the main complication of TLB with an average of 20%. Many risk factors, whether clinical, computed tomography or related to TLB, are described in the literature. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumothorax
- What is being tested?
- Needle lung biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2018to Apr 2019
- 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: See eligibilty criteria
Who may be able to join
- Patients having needle lung biopsy CT-guided for diagnostic purposes.
Who cannot join
- Nodule or mass in contact with the pleura for which the aerated pulmonary parenchyma is not crossed by the puncture needle.
- Several pulmonary sites biopsied.
- Existence of a pneumothorax before procedure
- Per-procedural appearance of alveolar or interstitial pneumonitis at the level of the biopsy area.
- Cavitary aspect of nodule or mass
- Absence of chest X-ray control
- Poorness quality of chest X-ray control
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Besançon
Besançon, Doubs, 25000
joffrey hamam, 0381668802 ext. +33, joffrey.hamam@live.fr
Jean-Charles Dalphin, 0381668802, jean-charles.dalphin@univ-fcomte.fr
About this study
Transthoracic lung biopsy (TLB) provides a histological diagnosis of nodule or lung mass. Pneumothorax is the main complication of TLB with an average of 20%. Many risk factors, whether clinical, computed tomography or related to TLB, are described in the literature. The British Thoracic Society recommends monitoring for 2 hours after the procedure with a possible discharge if the chest X-ray is normal. There is no French or European recommendation for monitoring the occurrence of pneumothorax after TLB. In the university center of Besançon, France, a minimum supervision of 4 hours is recommended and approximately one in two patients is hospitalized until the following day to reach this minimum time of 4 hours. The objective of the SPOT study is to perform a predictive score of pneumothorax from a retrospective cohort of patients for whom a transthoracic lung biopsy was performed and to validate this score on a prospective cohort. The expected goal is to select patients who can benefit from outpatient care by shortening the post-procedure surveillance period and to monitor more long-term only high-risk patients.
- Conditions
- Pneumothorax
- Being tested
- Needle lung biopsy
- Keywords
- Lung lesions, Pneumothorax, CT-guided transthoracic biopsy, Risk score
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Needle lung biopsyProcedure or surgery
Needle lung biopsy
| Study group | Role | What they receive |
|---|---|---|
| Retrospective cohort | All patients having a CT-guided transthoracic biopsy from September 2012 and September 2017. Receives: Procedure: Needle lung biopsy | |
| Prospective cohort | All patients having a CT-guided transthoracic biopsy from April 2018. Receives: Procedure: Needle lung biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pneumothorax occurrence
Pneumothorax is defined by the observation on the chest x-ray of a pleural detachment regardless of its importance.
Measured: between 4 and 24 hours after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start1 Apr 2018
- Primary completionApr 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumothoraxStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488043
- Sponsor's protocol ID
- P/2018/372
- Acronym
- SPOT
- Status last verified
- Mar 2018
- First submitted
- 26 Mar 2018
- Last updated
- 27 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lamfichekh Y, Lafay V, Hamam J, Guillien A, Puyraveau M, Behr J, Manzoni P, Calame P, Dalphin JC, Eberst G, Grillet F, Westeel V. Score to Predict the Occurrence of Pneumothorax After Computed Tomography-guided Percutaneous Transthoracic Lung Biopsy. J Thorac Imaging. 2023 Sep 1;38(5):315-324. doi: 10.1097/RTI.0000000000000729. Epub 2023 Jul 17.
PubMed 37603106
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Score of PneumOThorax Secondary to CT-guided Transthoracic Lung Biopsy Made From a Large Retrospective Cohort and Validated on a Prospective Cohort
- ClinicalTrials.gov ID
- NCT03488043
- Acronym / sponsor ID
- SPOT / P/2018/372
- Conditions
- Pneumothorax
- Keywords
- Lung lesions, Pneumothorax, CT-guided transthoracic biopsy, Risk score
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 4 Apr 2018 (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.
Transthoracic lung biopsy (TLB) provides a histological diagnosis of nodule or lung mass. Pneumothorax is the main complication of TLB with an average of 20%. Many risk factors, whether clinical, computed tomography or related to TLB, are described in the literature. The British Thoracic Society recommends monitoring for 2 hours after the procedure with a possible discharge if the chest X-ray is normal. There is no French or European recommendation for monitoring the occurrence of pneumothorax after TLB. In the university center of Besançon, France, a minimum supervision of 4 hours is recommended and approximately one in two patients is hospitalized until the following day to reach this minimum time of 4 hours. The objective of the SPOT study is to perform a predictive score of pneumothorax from a retrospective cohort of patients for whom a transthoracic lung biopsy was performed and to validate this score on a prospective cohort. The expected goal is to select patients who can benefit from outpatient care by shortening the post-procedure surveillance period and to monitor more long-term only high-risk patients.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective cohort | – | Procedure: Needle lung biopsyAll patients having a CT-guided transthoracic biopsy from September 2012 and September 2017. |
| Prospective cohort | – | Procedure: Needle lung biopsyAll patients having a CT-guided transthoracic biopsy from April 2018. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- See eligibilty criteria
Key inclusion criteria (1 listed)
- Patients having needle lung biopsy CT-guided for diagnostic purposes.
Key exclusion criteria (7 listed)
- Nodule or mass in contact with the pleura for which the aerated pulmonary parenchyma is not crossed by the puncture needle.
- Several pulmonary sites biopsied.
- Existence of a pneumothorax before procedure
- Per-procedural appearance of alveolar or interstitial pneumonitis at the level of the biopsy area.
- Cavitary aspect of nodule or mass
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 |
|---|---|---|
| Needle lung biopsyNeedle lung biopsy | Procedure or surgery | Prospective cohort, Retrospective cohort |
Primary outcome
Pneumothorax occurrence
Time frame: between 4 and 24 hours after procedure
Pneumothorax is defined by the observation on the chest x-ray of a pleural detachment regardless of its importance.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2018.
- Derived from this study: PubMed 37603106Lamfichekh Y, Lafay V, Hamam J, Guillien A, Puyraveau M, Behr J, Manzoni P, Calame P, Dalphin JC, Eberst G, Grillet F, Westeel V. Score to Predict the Occurrence of Pneumothorax After Computed Tomography-guided Percutaneous Transthoracic Lung Biopsy. J Thorac Imaging. 2023 Sep 1;38(5):315-324. doi: 10.1097/RTI.0000000000000729. Epub 2023 Jul 17.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumothorax, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 27 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joffrey Hamam (0381668802 ext. +33, joffrey.hamam@live.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pneumothorax occurrence (time frame: between 4 and 24 hours after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03488043, which also lists 1 linked publication.
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 27 Jul 2018.