Comparison of Loop-tip Cook Medical® Wire vs Traditional Endoscopic Technique Cannulation in the Prevention of Post-ercp Pancreatitis and Biliary Tree Access in High-risk Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 320
- 主要终点
- The evaluation of the incidence of PEP
研究概览
简要总结
The purpose of this study is to test a new guide-wire (loop-tip wire) with a loop in the tip for the prevention of PEP and biliary tree access, in post-ERCP pancreatitis in high-risk patients.
详细描述
Selective cannulation of common bile duct (CBD) by insertion of a guide-wire seems to be associated with fewer complication and post-ERCP pancreatitis (PEP) rate than the conventional biliary tree access with contrast injection even if results are conflicting. The aim of our study is to test a new guide-wire (loop-tip wire) with a loop in the tip for the prevention of PEP and biliary tree access, in PEP high-risk patients.
Type of study: Multicentric, prospective and randomized trial
Patients: PEP high-risk patients underwent ERCP for benign biliary pathology
Number of patients: 320 patients (160 for each group)
Aim:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •high risk patients for post-ERCP pancreatitis
排除标准
- •age < 18 yrs
- •allergy to the contrast medium
- •previous surgery
- •neoplastic bilio-pancreatic disease
- •previous EBS
结局指标
主要结局
The evaluation of the incidence of PEP
时间窗: loop20216
次要结局
- The evaluation of CBD percentage cannulation.(loop20216)
研究者
Enzo Masci
Chief of Gastrointestinal Endoscopy
Azienda Ospedaliera San Paolo