Raman Spectroscopy in the Diagnosis of Extrahepatic Cholangiocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The differences in Raman spectra of malignant biliary tissue compared to healthy biliary tissue
研究概览
简要总结
Diagnosis of extrahepatic cholangiocarcinoma is challenging because the yield of imaging and tissue sampling is limited. Raman spectroscopy is an optical method based on the analysis of scattered monochromatic light. Raman spectroscopy is able to provide a molecular 'fingerprint' of the tissue to determine its type. The aim of this pilot study was to develop a methodology for in vivo Raman spectroscopy in bile ducts to improve the current diagnostic capabilities of extrahepatic cholangiocarcinoma.
详细描述
During ERCP, a fibre Raman probe (Endoscopic Fiber-Optic Raman Probe Bundle Fiber, Uni-Export Instruments, USA) is introduced transpapillary into the known extrahepatic cholangiocarcinoma. The Raman probe is placed in an adequate position under fluoroscopy control. Raman spectroscopy measurements are performed (without fluoroscopy) 20 times for each patient (laser wavelength 785 nm), 10 times for extrahepatic cholangiocarcinoma and 10 times for healthy bile duct. The attained data are saved and analysed by a specialised biophysicist. All patients provided informed consent.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •person older than 18 years, who has known extrahepatic cholangiocarcinoma and is indicated for ERCP
排除标准
- •disagreement with the study
结局指标
主要结局
The differences in Raman spectra of malignant biliary tissue compared to healthy biliary tissue
时间窗: Perioperative/Periprocedural
During single ERCP procedure, we take 20 measurements of the Raman spectra (10 from malignant biliary tissue and 10 from healthy biliary tissue) that each tissue emits after interaction with the laser light. We are interested in the specific difference in the spectra of each tissue, which will be shown as a two-dimensional curve. The differences in the spectra of each tissue will be reflected by a change in the shape of the curve.
次要结局
未报告次要终点
研究者
Peter Slodicka
Doctor of Medicine, Clinical Doctor, Principal Investigator
University Hospital Olomouc