Endoscopic Ultrasound-guided Needle-based Confocal Laser Endomicroscopy for Diagnosis of Gastric Subepithelial Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- The nCLE interpretation criteria for the characterization of gastric subepithelial tumors with histopathological correlation
研究概览
简要总结
The differential diagnosis of gastric subepithelial tumors by endoscopic ultrasound 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 gastric subepithelial tumors, 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged from 18 to 75 years, with gastric subepithelial tumors ≥ 2 cm
排除标准
- •Previous EUS-FNA performed within the past 3 months, and usual contraindications to EUS-FNA, such as serous cardiopulmonary diseases, severe coagulopathy dysfunction, impaired kidney function
- •Extramural structures, vascular lesions or cystic masses were visible by EUS
- •Pregnancy or breastfeeding
- •Known allergy to fluorescein sodium
- •Inability to provide informed consent
- •Validation study
- •Inclusion Criteria:
- •patients aged from 18 to 75 years, with gastric subepithelial tumors ≥ 1 cm
- •Exclusion Criteria:
- •Previous EUS-FNA performed within the past 3 months, and usual contraindications to EUS-FNA, such as serous cardiopulmonary diseases, severe coagulopathy dysfunction, impaired kidney function
- •Extramural structures, vascular lesions cystic masses or lipoma were visible by EUS
- •Pregnancy or breastfeeding
- •Known allergy to fluorescein sodium
- •Inability to provide informed consent
结局指标
主要结局
The nCLE interpretation criteria for the characterization of gastric subepithelial tumors with histopathological correlation
时间窗: 24 months
The feasibility, safety and diagnostic yield of nCLE for gastric subepithelial tumors
时间窗: 24 months
次要结局
未报告次要终点
研究者
Yanqing Li
Official Title: Vice president of Qilu Hospital
Shandong University