Validation of Clinical Efficacy and Development of New Diagnostic Algorithm of Probe-based Confocal Laser Endomicroscopy in Patients With Lower Gastrointestinal Disorder
试验速览
- 阶段
- 不适用
- 入组人数
- 311
- 试验地点
- 1
- 主要终点
- Sensitivity of pCLE diagnosis
研究概览
简要总结
The aims of this research are to validate and develop of therapeutic strategies for patients with colorectal lesions in real time through pCLE(probe-based confocal laser endomicroscopy). Endomicroscopy is a technique for obtaining histology-like images from inside the human body in real-time. Total objections are 311 patients.
Specific research topics are as below.
- Diagnosis and classification of colon polyps through pCLE
- Evaluation of the depth of invasion of colorectal cancer or lateral growth type tumor through the pCLE
- Differential diagnosis of colorectal submucosal tumor through the pCLE
- Differential diagnosis of ileocecal ulcers through the pCLE
The study will be conducted to measure sensitivity, specificity, accuracy, amphoteric predict of pCLE diagnosis, and calculate the agreement of prediction compared to the pathological findings of lesions Check diagnostic agreement of technical phrases which are derived, the matching degree between observers, and will develope a new classification method based on this.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults over 20 years old
- •Patients with colorectal polyps
- •Patients who undergo endoscopic submucosal dissection (ESD) due to lateral spreading tumors or early colorectal cancer
- •Patients with submucosal tumor in colorectal cancer
- •Patients with ileocecal ulcers
- •Patients who consented to research
排除标准
- •Patients who are impossible to biopsy or polypectomy due to underlying diseases.
- •Patients who are not able to end the ESD because of a complication
- •Patients who are already known the cause of ileocecal ulcers before the pCLE.
- •Patients with contraindications to the use of disease fluorescent contrast agents
- •Patients who did not consent to research
- •Patients who are unsuitable for clinical trials in charge of the attending physician.
研究组 & 干预措施
endo group
colon polyp, early colon cancer, colorectal submucosal tumor, ileocecal ulcers
干预措施: probe-based confocal laser endomicroscopy (Procedure)
结局指标
主要结局
Sensitivity of pCLE diagnosis
时间窗: 2 weeks
The study will be conducted to measure sensitivity, specificity, accuracy, amphoteric predict of pCLE diagnosis, and calculate the agreement of prediction compared to the pathological findings of lesions.
次要结局
- Accuracy of pCLE diagnosis(2 weeks)
- Specificity of pCLE diagnosis(2 weeks)
- amphoteric predict of pCLE diagnosis(2 weeks)