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临床试验/NCT02028845
NCT02028845已完成不适用

Loop-tipped Guidewire in Selective Biliary Cannulation: a Prospective, Randomized, Controlled Trial

Ajou University School of Medicine2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2014年1月1日最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
2
主要终点
The cannulation success rate
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

  1. Background
  • Advanced guidewires with a U-shaped tip could effectively cross the long or multi-occlusive segment smoothly and go into the distal outflow vessel.
  • The guidewire looping technique is a safe and effective method for the recanalization of the occluded lesions in infrapopliteal vessels.
  1. Objective - To compare the performance a loop-tipped guidewire with a straight-tipped guidewire in achieving successful deep biliary cannulation.
  2. Design
  • Prospective randomized trial.
  1. Setting:
  • Tertiary-care medical center
  1. Patients
  • This study will involve 192 patients with biliary diseases which require endoscopic retrograde cholangiopancreatography.
  1. Intervention - Cannulation of bile duct by using a loop-tipped guidewire or a straight-tipped guidewire
  2. Main outcome measurements - Compare the cannulation success rate, the duration of the cannulation, immediate and late complications.

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
20 Years 至 90 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •age > 19 and ability to consent
  • •no evidence of significant cardiopulmonary or medical comorbidities precluding participation

排除标准

  • •Known gastroduodenal anatomic abnormalities
  • •Coagulation disorders (international normalized ratio > 1.5 or platelet count < 50000 cells/cubic millimeter)
  • •Prior gastric surgery,endoscopic retrograde cholangiopancreatography
  • •Pregnancy

结局指标

主要结局

The cannulation success rate

时间窗: Up to 9 months, The primary outcome measure will be assessed after the enrollment of patients (anticipated time: 2014/08/30).

次要结局

  • The duration of the cannulation, immediate and late complications.(Up to 9 months, The secondary outcome measure will be assessed after the enrollment of patients (anticipated time: 2014/08/30).)

研究者

发起方
Ajou University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yoo Byung Moo

Assistant Professor

Ajou University School of Medicine

研究点 (2)

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