Assessment of Cholangio-pancreatoscopy for the Diagnosis and the Treatment of Biliary and Pancreatic Diseases Trial " EASYSPY "
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 67
- 试验地点
- 3
- 主要终点
- Evaluate the diagnostic accuracy of the Spyglass to distinguish a benign lesion from a malignant lesion of the biliary or Wirsung ducts.
研究概览
简要总结
The biliary and pancreatic tumors are rare but the prognosis is pejorative. It was difficult to have histology of these tumors as the samples taken during ERCP were performed under " blind " radiology control. So the diagnostic accuracy was insufficient.
The arrival of A new optic fiber endoscope used by only one operator had improved the diagnostic of bilio-pancreatic diseases. However this technology with optic fiber quickly had proved outdated for several reasons: poor manoeuvrability, perfectible optical vision, optical fibers fragility and cost.
A new generation of endoscopes with digital vision appeared and would allow an increase in diagnostic accuracy related to better vision and manoeuvrability.
The purpose of the study is to assess the interest of the cholangio pancreatoscopy performed with digital vision.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 ≥ 18 years
- •Patients with biliary duct stenosis with undetermined etiology
- •Patients with pancreatic duct stenosis with undetermined etiology
- •Patients with pancreatic duct distension with undetermined etiology
- •Patients with biliary or pancreatic gallstones after failure to endoscopic treatment
排除标准
- •Patients with haemorrhagic disease or hemostasis and coagulation disorders (TP < 60%, TCA> 40 sec. and platelets < 60000/mm3).
- •Patients treated with anticoagulant or platelet aggregation inhibiting drugs that could not be temporarily interrupted.
- •Patients with biliary duct diameter < 3 mm
- •Patients with pancreatic duct diameter <3 mm
结局指标
主要结局
Evaluate the diagnostic accuracy of the Spyglass to distinguish a benign lesion from a malignant lesion of the biliary or Wirsung ducts.
时间窗: 4 YEARS
次要结局
未报告次要终点
研究者
Arthur Laquiere
Gastroenterologist
Hospital St. Joseph, Marseille, France