Comparison of the Sensitivity of Probe-based Confocal Laser Endomicroscopy and Pathological Biopsy Before Endoscopic Submucosal Dissection
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 169
- 试验地点
- 4
- 主要终点
- Sensitivity
研究概览
简要总结
Pathological biopsy before endoscopic submucosal dissection (ESD) the gastric lesion plays an important role in differentiating the pathological nature of the lesion and guiding treatment decisions. However, due to the influence of the materials used, the sensitivity of pathological biopsy is not satisfactory. Confocal Laser Endomicroscopy (CLE) is a technology that integrates a confocal microscope into an endoscope. It enables the acquisition of high-resolution microscopic images of the mucosal layer in real-time (with a magnification of up to 1000 times), and it is an optical biopsy technique. It has unique value in the determination of the pathological nature of gastric lesions. The main purpose of this study is to compare the sensitivity of pathological biopsy and CLE in differentiating the pathological nature of gastric lesions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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 aged 18 to 85 years who were scheduled for endoscopic submucosal dissection due to early-stage gastric cancer were consecutively enrolled.
排除标准
- •Severe cardiac or pulmonary dysfunction, impaired renal function, coagulopathy, pregnancy or lactation, allergy to fluorescein, and inability to provide informed consent.
结局指标
主要结局
Sensitivity
时间窗: The pathological results can be obtained within 10 working days after ESD treatment, which can be used for sensitivity calculation.
Sensitivity, also known as the true positive rate (TPR), refers to the proportion of individuals in the actual patient group that a diagnostic test can correctly identify as positive (i.e., accurately detect cases). High sensitivity means that this detection method can minimize the risk of missed diagnosis to the greatest extent and is suitable for screening diseases (such as infectious diseases and early cancer screening).
次要结局
- Accuracy(The pathological results can be obtained within 10 working days after ESD treatment, which can be used for the calculation of accuracy.)
- Specificity(The pathological results can be obtained within 10 working days after ESD treatment, which can be used for specific calculations.)