Predictive Score of PneumOThorax Secondary to CT-guided Transthoracic Lung Biopsy Made From a Large Retrospective Cohort and Validated on a Prospective Cohort

Study Overview
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Brief Summary
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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.

Official Title
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Predictive Score of PneumOThorax Secondary to CT-guided Transthoracic Lung Biopsy Made From a Large Retrospective Cohort and Validated on a Prospective Cohort

Conditions
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Pneumothorax

Intervention / Treatment
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* Procedure: Needle lung biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients having needle lung biopsy CT-guided for diagnostic purposes. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrospective cohort<br>All patients having a CT-guided transthoracic biopsy from September 2012 and September 2017. | Procedure: Needle lung biopsy<br>* Needle lung biopsy<br>|
| Prospective cohort<br>All patients having a CT-guided transthoracic biopsy from April 2018. | Procedure: Needle lung biopsy<br>* Needle lung biopsy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pneumothorax occurrence | Pneumothorax is defined by the observation on the chest x-ray of a pleural detachment regardless of its importance. | between 4 and 24 hours after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung lesions, Pneumothorax, CT-guided transthoracic biopsy, Risk score