A Randomized Controlled Trial of Rigid Versus Semirigid Thoracoscopy in the Evaluation of Exudative Pleural Effusions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Diagnostic yield of thoracoscopic biopsy by intention to treat analysis
研究概览
简要总结
Rigid thoracoscopy is an established procedure for the performance of pleural biopsies for undiagnosed pleural effusions. The semirigid thoracoscope is a relatively new instrument designed for the same purpose which is claimed to be more user-friendly. The two devices have not been compared in a head-to-head trial in published literature. The investigators attempt to conduct a randomised comparative trial between the two devices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an exudative (as defined by Light's criteria) pleural effusion of unknown etiology after a microbiological (namely gram stain and acid fast bacillus stain) and cytological examination
排除标准
- •Significant hypoxemia on room air
- •Hemodynamic instability
- •Significant cardiac disease (known myocardial infarction in last 6 weeks or presence of unstable angina)
- •Refractory cough
- •Lack of pleural space due to adhesions
- •Uncorrected coagulopathy
结局指标
主要结局
Diagnostic yield of thoracoscopic biopsy by intention to treat analysis
时间窗: 3 months
The proportion of patients where thoracoscopic pleural biopsy yielded a diagnosis that was consistent with the present clinical picture and the further follow-up of the patients, would be calculated and compared between the two arms
次要结局
- Yield of biopsies successfully completed(3 months)
- Complications(3 months)
- Scar size(At the end of the procedure)
- Biopsy size(At the end of the procedure)
研究者
Sahajal Dhooria
Senior Resident
Post Graduate Institute of Medical Education and Research, Chandigarh