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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2019-04-30

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.

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Detailed Description

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Conditions

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Pneumothorax

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Retrospective cohort

All patients having a CT-guided transthoracic biopsy from September 2012 and September 2017.

Needle lung biopsy

Intervention Type PROCEDURE

Needle lung biopsy

Prospective cohort

All patients having a CT-guided transthoracic biopsy from April 2018.

Needle lung biopsy

Intervention Type PROCEDURE

Needle lung biopsy

Interventions

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Needle lung biopsy

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No