The Incidence of Pneumothorax After CT-guided Lung Biopsy Performed With and Without Autologous Blood Patching: a Randomized Single-center Prospective Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Early Pneumothorax after biopsy
研究概览
简要总结
The aim of this prospective, randomized study is to compare the rate of postoperative pneumothorax between standard CT-guided core needle biopsy (CNB) versus CNB followed by autologous blood patch injection (ABPI).
详细描述
Pneumothorax is the most common complication of percutaneous lung biopsies. Reducing this risk is a goal of those who perform these procedures, particularly a reduction in large pneumothoraces requiring intervention (eg, pleural drainage) and hospitalization (Clayton et al. 2016). Recently, autologous blood patch injection (ABPI) inside the biopsy track has been suggested as an effective mean of sealing the punctured lung thus halting air loss and consequently pneumothorax (Graffy et al. 2017).
The aim of this prospective, randomized study is to compare the rate of postoperative pneumothorax between standard CT-guided core needle biopsy (CNB) versus CNB followed by ABPI.
In particular, the main objectives are to compare:
- incidence of immediate pneumothorax
- incidence of late pneumothorax (2 hrs)
- incidence of chest tube placement
- duration of the procedure
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients scheduled for lung biopsy will be asked to join this study. After signing the informed consent the subject will be randomized for ABPI vs CNB approach.
- •Inclusion criteria:
- •patients with pulmonary nodule requiring CT-guided lung biopsy.
排除标准
- •unfit for lung biopsy (INR >1.5, PLT <50.000, single lung);
- •unavailable venous access.
研究组 & 干预措施
CNB followed by ABPI.
17 gauge coaxial needle for a 18g ct-guided lung biopsy followed by autologous blood patch injection
干预措施: Autologous blood patch injection (ABPI) (Other)
CT-guided core needle biopsy (CNB)
18 gauge ct-guided lung biopsy
干预措施: CT-guided core needle biopsy (CNB) (Other)
结局指标
主要结局
Early Pneumothorax after biopsy
时间窗: Immediately after lung puncture
Early Pneumothorax after biopsy as seen by immediate post-biopsy CT and X-ray
次要结局
- Late Pneumothorax after biopsy(2-6 hours)