Efficacy And Safety Of Thoracoscopic Cryobiopsy In Patients With Undiagnosed Exudative Pleural Effusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- efficacy which determined by the diagnostic yield
研究概览
简要总结
To demonstrated the efficacy and safety of taking biopsy specimens from parietal pleura in undiagnosed exudative pleural effusion
详细描述
Pleural effusions are either transudate or exudate according to the biochemical analysis of aspirated pleural fluid. Thoracentesis or blind pleural biopsy may not provide a definitive diagnosis. Cryobiopsy has more successful diagnostic results than forceps biopsies with complications (only hemorrhage) during procedures. Cryobiopsy can obtain more diagnostic biopsies due to the size of the biopsies and best property in expressions of an artifact-free sample area
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients diagnosed as exudative pleural effusion according to Light criteria .informed written consents were taken from all patients enrolled in the study
排除标准
- •patients who refused participation ,patients unfit for medical thoracoscopy (MT) will be excluded from the study such as:Uncooperative patient ,Severe uncorrected hypoxemia in spite of continuous oxygen administration, because it's necessary to keep oxygen saturation above 90 % during procedure ,patients who could not tolerate the lateral decubitus position for a period long adequate to do the thoracoscopy, unstable cardiovascular or hemodynamic condition, uncorrected Coagulation defects and small pleural space
结局指标
主要结局
efficacy which determined by the diagnostic yield
时间窗: baseline
comparing forceps biopsy and cryobiopsy as regard: efficacy which determined by the diagnostic yield.
efficacy which determined by the size of biopsy
时间窗: baseline
comparing forceps biopsy and cryobiopsy as regard: efficacy which determined by the size of biopsy.
The incidence of complications
时间窗: baseline
comparing forceps biopsy and cryobiopsy as regard: Safety which determined by the incidence of complications
次要结局
未报告次要终点
研究者
Tamer Awad
Principal Investigator
Mansoura University