Novel Use of Extrapleural Autologous Blood Injection in CT-guided Percutaneous Lung Biopsy and Its Comparison to Intraparenchymal Autologous Blood Patch Injection: A Single-center, Prospective, Randomized, and Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 139
- 试验地点
- 2
- 主要终点
- To evaluate the rate of iatrogenic pneumothorax and the need for intervention with extrapleural autologous blood injection (EPABI)
研究概览
简要总结
The purpose of this study is to evaluate the rate of iatrogenic pneumothorax and the need for intervention with extrapleural autologous blood injection (EPABI) along with intraparenchymal autologous blood patch injection (IABPI) or IABPI-alone in CT-guided percutaneous lung biopsy.
详细描述
The mechanism of pneumothorax is postulated to be due to the air leakage through the puncture hole when the needle is removed after the biopsy. However, pneumothorax may occur during the needle insertion as the visceral pleura is punctured or during the biopsy procedure before needle removal. Prevent such leakage, the investigators planned to inject autologous blood into the extrapleural space to prevent pneumothorax during needle entry. The extrapleural autologous blood injection (EPABI) is expected to form a space-occupying hematoma pressing on visceral pleura as a sealant. The investigators planned to test the EPABI method in a prospective single-center randomized controlled study design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age
- •Referred for CT guided biopsy of lung lesion
- •Target lesion of any size
- •Target lesion located any away from visceral pleura based on the needle path
- •Needle path without transgression of a pleural fissure, bleb, or bulla is possible
- •Coaxial biopsy technique using Bard 19-Gauge introducer needle
- •Needle length =16
排除标准
- •Passage through non-aerated lung or tissue
- •More than 1 biopsy on the same side requiring more than 1 pleural puncture
- •History of prior ipsilateral lung interventions including:
- •Chest tube placement Surgery Pleurodesis Radiation treatment
结局指标
主要结局
To evaluate the rate of iatrogenic pneumothorax and the need for intervention with extrapleural autologous blood injection (EPABI)
时间窗: 1 years
the rate of pneumothorax
次要结局
未报告次要终点
研究者
Yasar Turk
Assistant Professor
Namik Kemal University