Probe-based Confocal Laser Endomicroscopy With Topical Cresyl Violet for Diagnosis of Colorectal Polyps
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The pCLE with topical CV interpretation criteria for the characterization of colorectal polyps with histopathological correlation
研究概览
简要总结
Probe-based confocal laser endomicroscopy (pCLE) has been shown to a reliable diagnostic method enabling in vivo microscopic imaging during ongoing endoscopy. Usually fluorescein then serves as a contrast agent for pCLE, but it does not allow direct nuclear visualization, must be injected, leads to a transient skin discoloration, and may have allergic side effects. This study aimed to establish a single topical dye, cresyl violet (CV) for pCLE imaging, to describe pCLE interpretation criteria for the characterization of colorectal polyps 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 polyps found during surveillance or screening colonoscopies.
排除标准
- •Contraindications to CV (such as allergy);
- •Pregnancy or breastfeeding;
- •Serous cardiopulmonary diseases, severe coagulopathy dysfunction, impaired kidney function;
- •Inability to provide informed consent.
结局指标
主要结局
The pCLE with topical CV interpretation criteria for the characterization of colorectal polyps with histopathological correlation
时间窗: 5 months
Number of diagnostic agreement between pCLE with topical CV and histopathological results
时间窗: 5 months
Number of participants with procedure-related adverse events
时间窗: 5 months
Number of pCLE imaging failure with topical CV
时间窗: 5 months
次要结局
未报告次要终点
研究者
Yanqing Li
Vice president of Qilu Hospital
Shandong University