Evaluation of Efficacy and Safety of Goff Transpancreatic Septotomy vs. Double Wire Technique for Achieving Biliary Access in Technically Challenging ERCPs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,600
- 试验地点
- 2
- 主要终点
- Successful biliary cannulation assessed by fluoroscopic confirmation of biliary cannulation
研究概览
简要总结
Randomized, prospective study evaluating efficacy and safety of Goff transpancreatic septotomy vs. double wire technique for achieving biliary access in patients who fail initial cannulation at ERCP.
详细描述
Selective placement of a guidewire into the bile duct (biliary cannulation) during endoscopic retrograde cholangiopancreatography (ERCP) is necessary for performing therapeutic biliary procedures. The success rate for biliary cannulation by experienced endoscopists during ERCP is approximately 85% with standard cannulation techniques. Inadvertent placement of the guidewire into the pancreatic duct rather than the bile duct often occurs when attempting selective biliary cannulation in technically challenging cases. When this occurs repeatedly, other approaches may be used to facilitate selective biliary cannulation, but there are few prospective studies evaluating the efficacy and safety of these approaches. Here the investigators evaluate two approaches for technically challenging biliary cannulation: one involving maintenance of a wire in the pancreatic duct, followed by repeat attempt at biliary cannulation (double wire technique) and one involving a small incision in the septum adjacent to the pancreas followed by repeat attempt at biliary cannulation (transpancreatic septotomy). This study is a prospective randomized trial comparing the rate of cannulation success, procedure duration and complications following these two approaches.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Age 18 and older
- •Patient has a clinical indication for ERCP
- •Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
排除标准
- •Potentially vulnerable subjects including, homeless people, pregnant females, employees and students.
- •Complex post-surgical anatomy e.g. Billroth type II anatomy, Roux-en-Y-gastrojejunostomy
- •Prior sphincterotomy or balloon dilation of ampulla
- •Thrombocytopenia, coagulopathy, or indication for ongoing anti-coagulation therapy
- •Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit
结局指标
主要结局
Successful biliary cannulation assessed by fluoroscopic confirmation of biliary cannulation
时间窗: Day of procedure
Successful biliary cannulation
次要结局
- Adverse event rates assessed by 6-month follow-up of clinical and laboratory studies(6 months)
研究者
Subhas Banerjee
Associate Professor of Medicine, Division of Gastroenterology
Stanford University
