NCT02813603已完成不适用
Comparison of the Diagnostic Yield Between Various Endobronchial Ultrasound-guided-transbronchial Needles (EBUS-TBN) to Evaluate Suspect Mediastinal and Hilar Lymph Nodes
University Hospital, Essen2 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2016年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- sample weight
研究概览
简要总结
Investigators intend to compare the 19-gauge needle and the 22-gauge-needle during EBUS-TBNA concerning the diagnostic yield, the quality and quantity of each biopsy needle without raising the rate of complications.
详细描述
Investigators intend to compare the 19-gauge needle and the 22-gauge-needle during EBUS-TBNA performed in rigid bronchoscopy for patients with probable lung cancer diagnosis and enlarged mediastinal lymph nodes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Male or female patients aged over 18
- •Patients signed written informed consent
- •Mediastinal or hilar enlarged lymph nodes (>10mm) in short axis radiological or clinical findings likely for lung cancer
排除标准
- •Severe impairment of any organs, with do not enable anaesthesia
- •Quick <80%, INR >1,5, thrombocytes <50/nl or PTT>120sec
- •Other clinically relevant medical or psychological diseases, which affect the patients judgement or ability to participate in this study.
- •Insufficient language ability (spoken and written German)
结局指标
主要结局
sample weight
时间窗: February 2017
次要结局
- The number of complications like bleeding, infections, pneumothorax and pain(February 2017)
研究者
Kaid Darwiche
Priv. Doz. Dr. med. Kaid Darwiche
University Hospital, Essen
研究点 (2)
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