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临床试验/NCT04770857
NCT04770857Unknown不适用

Evaluation of Post-Post-Endoscopic Retrograde Cholangiopancreaticography Pain (ERCP) as a Predictor for Post-ERCP Pancreatitis

Nicola Frei1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,000
试验地点
1
主要终点
Association between Pain 1 hour after ERCP

研究概览

简要总结

Pancreatitis is the most common complication after ERCP, although its frequency varies significantly depending on the study from < 2% up to 40%.

Based upon data from studies that have included unselected patients, post-ercp pancreatitis (PEP) is mild, moderate, and severe in 45%, 44%, and 11% of cases, respectively. Dysfunction of the sphincter Oddi, female gender, younger age, previous history of pancreatitis, prolonged procedure time and pancreatic guidewire passages are well-known independent risk factors for PEP.

This study will assess whether the development of PEP can be predicted by Visual analogue scale (VAS) level 1 hour after ERCP.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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 years
  • Scheduled for ERCP for any reason

排除标准

  • Absence of consent
  • Language barrier
  • No endoscopic advance to the papilla vateri
  • Active pancreatitis at the time of the procedure
  • Mental disability

结局指标

主要结局

Association between Pain 1 hour after ERCP

时间窗: 1 hour

次要结局

  • Predictive value of VAS for PEP Predictive value of VAS for PEP(1 hour)
  • Association between VAS level and severity of PEP(1 hour)

研究者

发起方
Nicola Frei
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nicola Frei

MD

Cantonal Hospital of St. Gallen

研究点 (1)

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