Pleural Cryobiopsies During Semirigid Thoracoscopy: A New Technique
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Number / percent of patients with useful pleural biopsy sample, obtained by cryoprobe
研究概览
简要总结
The purpose of this study is to determine feasibility of pleural biopsies with the cryoprobe during semirigid thoracoscopy. The secondary aim is to evaluate safety with focus on bleeding intensity.
详细描述
The primary aim of this study is to determine feasibility of pleural biopsies with the cryoprobe during semirigid thoracoscopy. We will assess size, morphological features, immunohistochemistry and diagnostic yield as measures of the quality of the samples. The secondary aim is to evaluate safety with focus on bleeding intensity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Pleural symphisis, fibrothorax
结局指标
主要结局
Number / percent of patients with useful pleural biopsy sample, obtained by cryoprobe
时间窗: 12 months
To determine, wheather cryobiopsy specimen can be obtained in each patient
Size of biopsy samples
时间窗: 12 months
Size of the biopsy specimens in mm2
Quality of the sample
时间窗: 12 months
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) Assessment of biopsy-related artifacts by describing the amount of unaltered tissue in quartiles
次要结局
- Bleeding(1 month)
研究者
Aleš Rozman
Head of endoscopy department
The University Clinic of Pulmonary and Allergic Diseases Golnik