Endoscopic Ultrasound-guided Needle-based Confocal Laser Endomicroscopy in Solid Pancreatic Masses
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 pancreatic masses with histopathological correlation
研究概览
简要总结
The differential diagnosis of solid pancreatic masses by endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is currently suboptimal. 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 describe nCLE interpretation criteria for the characterization of pancreatic masses, with histopathological correlation, and to perform the validation of these criteria.
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 with any pancreatic mass
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 pancreatic masses with histopathological correlation
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