Efficacy of semi-rigid thoracoscopic pleural cryo vs. forceps biopsy for evaluation of undiagnosed exudative pleural effusion.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To evaluate and compare the diagnostic efficacy of semi-rigid thoracoscopic pleural cryobiopsy
研究概览
简要总结
Demographic and historical data of eligible patients will be documented, including age, sex,
radiological findings, and results of diagnostic thoracocentesis and ultrasound-guided biopsy if performed.
Patients will also undergo semirigid thoracoscopy if standard thoracocentesis and ultrasound-guided
biopsy are inconclusive. Pleural biopsies will be collected using a cryoprobe (19mm) and semirigid forceps
biopsy, with eight biopsies taken using flexible forceps and four using a cryoprobe.
The operator will assess the ease of biopsy acquisition using a visual analogue scale, documenting
post-biopsy bleeding and procedure duration.
Biopsies from each method will be tagged separately and sent for histopathological examination.
The samples will be followed up in the Pathology department to evaluate biopsy size, crush artifacts,
ease of diagnosis, and final diagnosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age more than 18 years 2.Presence of exudative pleural effusion 3.Absence of definitive diagnosis even after thoracocentesis and USG guided biopsy (if indicated).
排除标准
- •Unstable respiratory, cardiovascular, hemodynamic condition or uncorrected coagulation defects
- •Small pleural space or multiple adhesions visualized in ultrasound necessitating the use of rigid thoracoscopy.
结局指标
主要结局
To evaluate and compare the diagnostic efficacy of semi-rigid thoracoscopic pleural cryobiopsy
时间窗: baseline, 1-2 weeks post procedure
versus forceps biopsy in cases of undiagnosed exudative pleural effusions
时间窗: baseline, 1-2 weeks post procedure
次要结局
- 1.To evaluate the major and minor complications of semi-rigid thoracoscopic pleural biopsy.(2. To assess and compare semi rigid thoracoscopic pleural cryobiopsy and forceps biopsy in terms of)
研究者
Amal V Raj
VMMC and SJH