Clinical Trials Directory

Trials / Unknown

UnknownNCT03488043

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

Status
Unknown
Phase
Study type
Observational
Enrollment
1,000 (estimated)
Sponsor
Centre Hospitalier Universitaire de Besancon · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURENeedle lung biopsyNeedle lung biopsy

Timeline

Start date
2018-04-01
Primary completion
2019-04-01
Completion
2019-04-01
First posted
2018-04-04
Last updated
2018-07-27

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03488043. Inclusion in this directory is not an endorsement.