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

Pneumothorax Clinical Trial

— SPOT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03488043
• Other study ID #: P/2018/372
• Status: Recruiting
• Start date: April 1, 2018
• Est. completion date: April 2019

Study information

• Verified date: March 2018
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Joffrey Hamam
• Phone: 0381668802
• Email: joffrey.hamam[@]live.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumothorax

Intervention

Procedure:
• Needle lung biopsy
Needle lung biopsy

Locations

Country	Name	City	State
France	CHU Besançon	Besançon	Doubs

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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