Predictive Score of PneumOThorax Secondary to CT-guided Transthoracic Lung Biopsy Made From a Large Retrospective Cohort and Validated on a Prospective Cohort
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Pneumothorax occurrence
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients having needle lung biopsy CT-guided for diagnostic purposes.
排除标准
- •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
结局指标
主要结局
Pneumothorax occurrence
时间窗: 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.
次要结局
未报告次要终点
