NCT02939066Unknown不适用
Endoscopic Ultrasound-guided Needle-based Confocal Laser Endomicroscopy for Evaluation of Malignant Lymph Nodes - a Pilot Study
Shandong University1 个研究点 分布在 1 个国家目标入组 30 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
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The nCLE interpretation criteria for the characterization of malignant lymph nodes
研究概览
简要总结
Current modalities for lymph node staging in cancer can be limited. Needle-based confocal laser endomicroscopy (nCLE) is a novel endoscopic technique, which is compatible with the 19-gauge FNA needle. Under endoscopic ultrasonography (EUS) guidance, nCLE enables real-time in vivo imaging of lesion tissues at cellular and subcellular levels.This study aimed to evaluate the feasibility of needle-based confocal laser endomicroscopy (nCLE) at the time of endoscopic ultrasound (EUS) and to describe the nCLE features that distinguish between benign and malignant lymph nodes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing EUS for staging of malignancy or assessment of enlarged lymph nodes
排除标准
- •Patients aged <18 years or >80 years
- •Known allergy to fluorescein dye
- •Previous EUS-FNA performed within the past 3 months, and usualcontraindications to EUS-FNA
- •Pregnancy or breastfeeding
- •Inability to provide informed consent
结局指标
主要结局
The nCLE interpretation criteria for the characterization of malignant lymph nodes
时间窗: 20 months
次要结局
未报告次要终点
研究者
Yanqing Li
Vice president of Qilu Hospital
Shandong University
研究点 (1)
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