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Clinical Trials/NCT03488043
NCT03488043
Unknown
Not Applicable

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

Centre Hospitalier Universitaire de Besancon1 site in 1 country1,000 target enrollmentApril 1, 2018
ConditionsPneumothorax

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pneumothorax
Sponsor
Centre Hospitalier Universitaire de Besancon
Enrollment
1000
Locations
1
Primary Endpoint
Pneumothorax occurrence
Last Updated
7 years ago

Overview

Brief 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. 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.

Registry
clinicaltrials.gov
Start Date
April 1, 2018
End Date
April 2019
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Study Sites (1)

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