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

Centre Hospitalier Universitaire de Besancon

Status: Unknown

Conditions: Pneumothorax

Treatments: Procedure: Needle lung biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT03488043

P/2018/372

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 2 patient groups

Retrospective cohort

Description:

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

Treatment:

Procedure: Needle lung biopsy

Prospective cohort

Description:

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

Treatment:

Procedure: Needle lung biopsy