Intra-ductal Confocal Endomicroscopy for Characterization of Pancreas and Bile Duct Tumor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The principal outcome is the percentage of successful in vivo examination according to the localisation of the stenosis. A successful examination is defined by the obtention of exploitable image for the anatomopathology.
研究概览
简要总结
The endomicroscopy is an adaptation of traditional optical microscopy in the digestive endoscopy. Furthermore, with the integration of a miniaturized laser confocal microscope to a videoendoscope, it's possible to study the digestive mucous by "optical biopsy". This monocentric, non randomized and prospective study uses the Intra-ductal confocal endomicroscopy for the characterization of pancreas and bile duct tumor.
详细描述
Primary objective:
Obtain a tissular characterization of a biliary or pancreatic stenosis with a confocal microscope which is in direct contact of the stenosis during the Endoscopic Retrograde Cholangio-Pancreatography (ERCP).
Secondary objectives:
- Compare the result of this "optical biopsy" to a conventional biopsy.
- Tolerance
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
- •Patients aged from 18 to older
- •Patient with an inflammatory or tumoral stenosis of bile duct or a solid or cystic tumor in the pancreas with a dilatation of the principal pancreatic canal.
- •Signed consent
- •Non inclusion Criteria:
- •Patient who have no indication for an ERCP
- •Allergy to fluorescein
- •Allergic rhinitis, asthma, eczema
- •Pregnancy, breast feeding
- •Patients with dialysis
- •Patient with severe heart failure
- •Patient with cirrhosis
- •Hemostasis failure which can induce difficulties or contraindication for the biopsy during the conventional endoscopy
排除标准
- 未提供
结局指标
主要结局
The principal outcome is the percentage of successful in vivo examination according to the localisation of the stenosis. A successful examination is defined by the obtention of exploitable image for the anatomopathology.
时间窗: 2 days
次要结局
- Study of the concordance between optical and histological biopsy(2 days)
- Frequency and grade of adverse effects induced by the confocal endomicroscopy(2 days)