Use of Probe-based Confocal Laser Endomicroscopy to Perform Optical Biopsy for Peritoneal Nodules in Colorectal Cancer Patients During Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 278
- 试验地点
- 1
- 主要终点
- Accuracy of pCLE optical biopsy
研究概览
简要总结
During surgery, peritoneal metastasis is typically confirmed pathologically through resection sample. However, this process can be time-consuming when utilizing intro-operative frozen section pathology. To address this issue, we propose utilizing confocal laser endomicroscopy to provide in situ, real-time, and in-vivo diagnosis of suspected peritoneal nodules as cancer metastasis during surgery.
详细描述
Peritoneal metastasis is a common metastatic site in colorectal cancer patients, and those with peritoneal metastasis often have a poor prognosis. During surgery, peritoneal metastasis is confirmed pathologically through resection sample, but frozen section pathology can take up to 30 minutes, which is a significant amount of time.
To address this issue, we suggest utilizing probed-based confocal laser endoscopy (pCLE), a novel endoscopic adjunct that enables real-time in vivo histological examination of mucosal surfaces. By using intravenous fluorescent agents, pCLE highlights certain mucosal elements that facilitate an optical biopsy in real time.
By providing a promising optical biopsy, CLE has the potential to enable in situ, real-time, and in vivo diagnosis of colorectal cancer patients with peritoneal nodules during surgery.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from over 18 to under 85 years
- •American Society of Anesthesiology (ASA) score class I,II,or III
- •Colorectal cancer
- •Patients who be about to undergo surgical treatment
- •Written informed consent
排除标准
- •Pregnant or lactating women
- •Acute renal insufficiency or stage II to IV chronic renal insufficiency
- •Patients with severe liver damage
- •Asthma patients or patients with allergic constitution
结局指标
主要结局
Accuracy of pCLE optical biopsy
时间窗: 7 days
The investigators will use pCLE optical biopsy for peritoneal nodules in colorectal cancer patients and compare the pathological diagnosis between optical biopsy and surgically resected specimens.
次要结局
- Sensitivity, specificity of pCLE optical biopsy(7 days)
- The positive predictive value and negative predictive value of pCLE optical biopsy(7 days)