NCT02763540已完成不适用
Le rôle de la Cryobiopsie Transbronchique Dans le Diagnostic Des Maladies Pulmoniares Interstitielles
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 4
- 主要终点
- The percentage of concordant diagnoses between cryobiopsy and surgical lung biopsy.
研究概览
简要总结
Pathological comparisons of surgical open lung biopsies and cryobiopsies in non-IPF ILD. Patients with non-IPF ILD eligible for an open lung biopsy will undergo cryobiopsy in the same time. Between observers agreement will be assessed for each pairs of samples.
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
- •Non IPF ILD eligible for surgical lung biopsy reviewed during multidisciplinary approach
排除标准
- •Ineligible for lung biopsy: pulmonary hypertension, coagulation deficiency, FEV<11, giant emphysematous bullae, hemodynamic instability severe hypoxia, general anesthetic ineligibility
结局指标
主要结局
The percentage of concordant diagnoses between cryobiopsy and surgical lung biopsy.
时间窗: for statistical analysis, 12 months after the first inclusion
The gold standard is the consensual diagnosis between the two readers established from surgical biopsy
次要结局
- The time of the gesture and the respective anesthetic complexities of each procedure(One day after inclusion)
- The rate of adverse events(for statistical analysis, 12 months after the first inclusion)
- The percentage homology intra and inter observer for histopathological analysis of each type of sample by Mac Nemar test(for statistical analysis, 12 months after the first inclusion)
- The number of elementary lesions actually present in the two samples for the same patient(One day after inclusion)
- The percentage homology between diagnosis obtained by surgical biopsy and cryobiopsy with the multidisciplinary approach(one day after inclusion)
研究者
研究点 (4)
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