A Study to Evaluate the Yield of Pleural Biopsy With a Flexible Cryoprobe Versus Flexible Forceps During Semirigid Thoracoscopy: a Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Yield of pleural biopsy obtained with the routine flexible thoracoscopic biopsy forceps versus that obtained with a flexible cryoprobe during semirigid thoracoscopy
研究概览
简要总结
This is a prospective study to assess the yield of pleural biopsy obtained with the routine flexible thoracoscopic biopsy forceps versus that obtained with a flexible cryoprobe during semirigid thoracoscopy
详细描述
Consecutive patients with exudative pleural effusions who are planned to undergo semirigid thoracoscopy will be enrolled in the study if they satisfy the inclusion criteria. They will be randomized in 1:1 ratio using a computer-generated randomization sequence to the following groups:
Group A: Four pleural biopsy specimens obtained using the flexible cryoprobe followed by eight pleural biopsy specimens obtained using the flexible thoracoscopic forceps OR Group B: The above two procedures will be performed in the reverse order The biopsies will be performed from different areas of the involved pleura with the two techniques. Thoracoscopy will be performed in the bronchoscopy suite on spontaneously breathing subjects (fasting for 8 h) under conscious sedation (using midazolam, pentazocine, and tramadol) observing complete aseptic precautions.
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 79 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥12 years
- •Semirigid thoracoscopy being performed for diagnosis of the pleural effusion
排除标准
- •Age ≥80 years
- •SpO2 <88% on room air
- •Hemodynamic instability
- •Myocardial infarction or unstable angina in the last 6 wk
- •Lack of pleural space due to adhesions
- •Uncorrected coagulopathy
- •Failure to provide informed consent
研究组 & 干预措施
Forceps biopsy
Pleural biopsy with a flexible forceps
干预措施: Flexible forceps biopsy first (Device)
Cryobiopsy
Pleural biopsy with a flexible cryoprobe
干预措施: Cryoprobe pleural biopsy first (Device)
结局指标
主要结局
Yield of pleural biopsy obtained with the routine flexible thoracoscopic biopsy forceps versus that obtained with a flexible cryoprobe during semirigid thoracoscopy
时间窗: One week
The proportion of patients where a definitive histopathological diagnosis was obtained will be compared between the cryoprobe and flexible forceps biopsy
次要结局
- Duration of procedure(One day)
- Artifacts(One day)
- Biopsy size(One day)
- Ease of biopsy VAS(One day)
- Tissue depth(One day)
- Bleeding(One day)
研究者
Sahajal Dhooria
Assistant Professor
Post Graduate Institute of Medical Education and Research, Chandigarh