Rigid Versus Semirigid Thoracoscopy in Diagnosing Pleural Diseases: a Randomized Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- diagnostic adequacy of semirigid thoracoscopy
研究概览
简要总结
The purpose of our study was to compare the size and the quality of biopsy samples together with the diagnostic adequacy of semirigid thoracoscopy with that of rigid instrument in prospective, randomized fashion. The second aim was to compare safety and tolerability of both types of procedure, performed in local anesthesia with addition of intravenous sedation and analgesia.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 or more years old
- •unilateral pleural effusion of unknown origin
- •pleural irregularities suspicious for pleural malignancy
- •referral for thoracoscopy after less invasive means of diagnosis had failed
排除标准
- •uncontrolled bleeding tendency
- •unstable cardiovascular status
- •severe heart failure
- •ECOG performance status 4
- •persistent hypoxemia after evacuation of pleural fluid
结局指标
主要结局
diagnostic adequacy of semirigid thoracoscopy
时间窗: 12 months
* comparison of diagnostic adequacy of both instruments (number of definitive diagnosis in each group) * size of the biopsy specimens in mm2 * interpretability of biopsy specimens in histopathology terms: 1. easily interpretable (enough tissue with all elements required for diagnosis) 2. interpretable with some difficulty (less tissue or diagnostic elements - diagnosis less reliable) 3. interpretable with great difficulty (little tissue or scarce diagnostic elements - low reliability of diagnosis) 4. non-interpretable (diagnosis not possible)
次要结局
- safety(1 month)
研究者
Aleš Rozman
MD
The University Clinic of Pulmonary and Allergic Diseases Golnik