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临床试验/NCT03263481
NCT03263481已完成不适用

Intraductal Secretin Stimulation Test: What Is the Proper Collection Time?

Indiana University2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2017年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
2
主要终点
Secretory flow rates measured by volume

研究概览

简要总结

The aim is to evaluate the peak secretory flow rates and bicarbonate concentrations as determined by a 30 minute intraductal secretin stimulation test in patients with a low likelihood of pancreatic pathology and to compare these data to those obtained from our historical patients with suspected chronic pancreatitis. These will be patients in which inadvertent pancreatic cannulation occurs during therapeutic endoscopic retrograde cholangiopancreatography (ERCP) for biliary indications . All study subjects will receive a 5 day follow-up phone call. Enrollment goal is 36 subjects.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
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

  • Male or female patients ≥ 18 years of age referred to Indiana University Health, University Hospital for ERCP for a biliary indication, at the discretion of the treating MD (e.g. suspected common bile duct stone, initial post-liver transplant evaluation, suspected or confirmed cholangiocarcinoma, suspected primary sclerosing cholangitis -- see exclusion criterion #12)

排除标准

  • Pregnant woman or breast feeding
  • Age <18 years
  • Patient unable to give informed consent
  • Patient with a history of pancreatic surgery
  • Patient with a history of pancreatic cancer
  • Patient with a history of acute or chronic pancreatitis
  • Patient with radiographic evidence of acute or chronic pancreatitis on CT, MRCP, or EUS
  • Patient with a current or prior history of average daily alcohol consumption of greater than 60 g per day for more than 2 years
  • Patient with a history of cigarette smoking greater that 20 pack-years
  • Patient with a history of pancreas divisum
  • Evidence of chronic pancreatitis on pancreatogram during ERCP
  • ERCP for an isolated biliary indication with previous biliary sphincterotomy or for biliary stent exchange, when pancreatic entry should easily be avoided by the endoscopist.
  • History of allergy or adverse reactions to secretin

结局指标

主要结局

Secretory flow rates measured by volume

时间窗: 30 minutes

Volume of pancreatic juices will be collected

Bicarbonate concentration of timed pancreatic juice

时间窗: 30 minutes

Concentration of bicarbonate levels will be determined

次要结局

未报告次要终点

研究者

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

Evan Fogel

Professor of Medicine

Indiana University

研究点 (2)

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