跳至主要内容
临床试验/NCT03118973
NCT03118973已完成不适用

Evaluation of Efficacy and Safety of Goff Transpancreatic Septotomy vs. Double Wire Technique for Achieving Biliary Access in Technically Challenging ERCPs

Subhas Banerjee2 个研究点 分布在 1 个国家目标入组 1,600 人开始时间: 2016年9月27日最近更新:
适应症

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

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

发起方
Subhas Banerjee
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Subhas Banerjee

Associate Professor of Medicine, Division of Gastroenterology

Stanford University

研究点 (2)

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