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临床试验/NCT01745978
NCT01745978Unknown3 期

The Efficacy and Safety of Precut Papillotomy Using the Knob-tipped Knife and Needle Knife in Difficult Biliary Cannulation: a Randomized-controlled Trial.

Changhai Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年12月最近更新:
适应症

试验速览

阶段
3 期
入组人数
50
试验地点
1
主要终点
Successful biliary cannulation rate after precut papillotomy

研究概览

简要总结

The aim of the present study was to compare the efficacy and safety of the knob-tipped knife and needle knife for precut papillotomy in difficult common bile duct (CBD)cannulation.

详细描述

Precut sphincterotomy is an alternative technique used to facilitate CBD cannulation following the failure of conventional bile duct cannulation. Needle knife papillotomy is the most widely practiced precut technique. However,Pre-cutting the papilla with a needle-knife is difficult, requiring experience and dexterity to control the axis and depth of the cut. Due to the increased rate of complications associated with this procedure, including pancreatitis, hemorrhage, and perforation, it was recommended to be performed only by experienced endoscopists.

The knob-tipped knife, a novel instrument utilizing a 2mm or 1.5mm cutting knife, is usually used for endoscopic submucosal dissection (ESD). Its knob-shaped tip and nonadjustable length make the knife less likely to slip and penetrate the tissue during the resection. Since the process of precut papillotomy is similar to ESD, the precutting procedure with the knob-tipped knife may be easier to be performed, as well as be safer. The efficacy and safety of this instrument in precut papillotomy have not been reported. We therefore assessed the efficacy and safety of the knob-tipped knife in precut papillotomy in difficult CBD cannulation.

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
Single (Outcomes Assessor)

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

入选标准

  • intact papilla and deep cannulation of the bile duct
  • a standard wire-guided cannulation >10 minutes, OR Pancreatic contrast injections ≥3, OR Pancreatic deep wire pass ≥5

排除标准

  • ampullary tumors
  • Billroth II or Roux-en-Y anatomy
  • prior endoscopic sphincterotomy(EST) or biliary stent
  • choledochoduodenal fistulae

结局指标

主要结局

Successful biliary cannulation rate after precut papillotomy

时间窗: During endoscopic retrograde cholangiopancreatography (ERCP) procedure

次要结局

  • Biliary cannulation time after precut papillotomy(From precut papillotomy started to biliary cannulation achieved or abandoned)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhaoshen Li

Director of Gastroenterology

Changhai Hospital

研究点 (1)

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