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临床试验/NCT03649399
NCT03649399已完成不适用

Sonographic Detection of Pancreatic Stents Placed for Prophylaxis of Post-ERCP Pancreatitis

Johann Wolfgang Goethe University Hospital1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2018年3月1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
41
试验地点
1
主要终点
Positive predictive value of the sonographic detection of pancreatic stents

研究概览

简要总结

The Retention of pancreatic stents for prophylaxis of post-ERCP pancreatitis (PEP) is assessed by abdominal x-ray according to international Guidelines. The current study aimed to analyze whether prophylactic pancreatic stents can be detected by transdermal ultrasound to save the x-ray examination.

详细描述

Pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). Several pharmacologic and procedure-related measurements have been established for post-ERCP pancreatitis (PEP) prophylaxis one being the placement of pancreatic duct stents in patients with high risk for PEP. The beneficial role of pancreatic stenting in the prophylaxis of PEP was demonstrated in large meta-analyses. The used stents have a high potential of self dislodgment, retained stents have to be removed endoscopically after 5-10 days. For evaluation of spontaneous stent passage abdominal x-ray ist used and accordingly retained stents removed. The current study aimed to analyze whether prophylactic pancreatic stents can be detected by transdermal ultrasound to save the x-ray examination.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patient after pancreatic stent placement for prophylaxis of post-ERCP pancreatitis
  • age 18-79
  • signed informed consent

排除标准

  • any disease that rules out study participation
  • patient not legally competent to sign informed consent
  • chronic pancreatis as indication for pancreatic stenting

结局指标

主要结局

Positive predictive value of the sonographic detection of pancreatic stents

时间窗: 5-10 days after stent placement

Test whether the stents can be detected reliably by ultrasound

次要结局

  • Negative predictive value of the sonographic detection of pancreatic stents(5-10 days after stent placement)

研究者

发起方
Johann Wolfgang Goethe University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Georg Dultz

Prof.

Johann Wolfgang Goethe University Hospital

研究点 (1)

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