Diagnostic Yeld of Ultrathin Bronchoscopy in Peripheral Pulmonary Lesions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 148
- 试验地点
- 3
- 主要终点
- Evaluate the overall diagnostic accuracy
研究概览
简要总结
The use of an ultrathin bronchoscope (UB) has recently been introduced in the diagnosis of peripheral lung lesions. The use of the UB can be supported by navigation systems such as fluoroscopy, ultrasound guidance, electromagnetic navigation, or other technologies, which have complementary potential. Further navigation techniques are still under study. The use of ultrathin instrumentation has already been shown to significantly reduce procedural times compared to traditional instrumentation.
The purpose of the study is to prospectively evaluate the institutional experience of different third-level hospital centers with the use of a UB (MP190F; Olympus Medical Systems, Tokyo, Japan) for sampling peripheral lung lesions by means of transbronchial needle aspiration (TBNA) or transbronchial biopsy (TBB), performed after fluoroscopic navigation and simultaneous radial probe-endobronchial ultrasound (RP-EBUS) assessment.
Design: multicentric, observational study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Evaluate the overall diagnostic accuracy
时间窗: Within 12 months from the procedure
Sensitivity, specificity, positive predictive value, negative predictive value
次要结局
- Agreement between the definitive pathological result and the rapid on-site evaluation (R.O.S.E.)(Within 15 days from the procedure)
- Evaluation of patient satisfaction at the end of the procedure (Likert scale in relation to the memory of the procedure and the willingness to repeat it in the future.)(Same day of the procedure)
- Correlation between the type of anesthesia, the characteristics of the lesion, the procedural dynamics and diagnostic accuracy(Within 12 months from the procedure)
- Correlation between the type of anesthesia, the characteristics of the lesion, the procedural dynamics and patient satisfaction(Same day of the procedure)
研究者
Alberto Fantin
Principal Investigator
Azienda Sanitaria-Universitaria Integrata di Udine