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

• Conditions: Pneumothorax
• Interventions: Procedure: Needle lung biopsy

• Registration Number: NCT03488043
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-03
• Study First Submitted: 2018-03-26
• Study Start: 2018-04-01
• Study First Submitted QC: 2018-04-03
• Study First Posted: 2018-04-04
• Last Update Submitted: 2018-07-26
• Last Update Posted: 2018-07-27
• Primary Completion: 2019-04
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Retrospective cohort	Needle lung biopsy	All patients having a CT-guided transthoracic biopsy from September 2012 and September 2017.
Prospective cohort	Needle lung biopsy	All patients having a CT-guided transthoracic biopsy from April 2018.

Primary Outcome Measures

Name	Time	Method
Pneumothorax occurrence	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.

Trial Locations

Locations (1)

CHU Besançon; 🇫🇷 Besançon, Doubs, France