An Open-Label Study On The Effects Of Human Secretin For Injection (CHIROSTIM) On Pancreatic Fluid Composition In Normal Human Volunteer Participants
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pancreatic Fluid Bicarbonate Composition
研究概览
简要总结
The purpose of this study is to collect pancreas fluid from the duodenum using the endoscopic pancreas function collection method in healthy participants after pancreatic stimulation with human secretin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or non-pregnant females
- •Participants must be in good health based on medical history (ASA Class 3 or below)
- •Participants must be willing and able to provide informed consent
- •Receiving an endoscopic ultrasound for a non-pancreatic indication
排除标准
- •History of any form of pancreatitis and/or other pancreatic diseases (e.g. pancreatic cysts, pancreatic masses).
- •History of inflammatory bowel disease
- •History of vagotomy.
- •History of surgically altered upper gastrointestinal anatomy (e.g. gastric bypass, Billroth I/II)
- •History of liver disease
- •Pregnant women or nursing mothers
- •Regular use of anticholinergics
- •> 2 drinks of alcohol daily
- •Smokers (cigarette)
研究组 & 干预措施
Healthy Participants
Healthy participants without pancreatic disease who are undergoing an endoscopic ultrasound for a non-pancreatic indication. This arm will be stratified into 3 age groups: 18-35, 35-45, and 46+ years. Participants will be given a standard dose of intravenous human secretin (0.2 mcg/kg) during the endoscopic ultrasound. During this time, pancreatic fluid will be collected at 5 minutes, 10 minutes, 15 minutes, and 20 minutes after secretin administration.
干预措施: Secretin (human synthetic) - ChiRhoClin (Drug)
结局指标
主要结局
Pancreatic Fluid Bicarbonate Composition
时间窗: 5, 10, 15, and 20-minutes post-secretin administration
A primary outcome will be the bicarbonate level (milliequivalent per liter) in the pancreatic fluid collected.
Pancreatic Fluid Sodium Composition
时间窗: 5, 10, 15, and 20-minutes post-secretin administration
A primary outcome will be the sodium level (milliequivalent per liter) in the pancreatic fluid collected.
Pancreatic Fluid Potassium Composition
时间窗: 5, 10, 15, and 20-minutes post-secretin administration
A primary outcome will be the potassium level (milliequivalent per liter) in the pancreatic fluid collected.
Pancreatic Fluid Chloride Composition
时间窗: 5, 10, 15, and 20-minutes post-secretin administration
A primary outcome will be the chloride level (milliequivalent per liter) in the pancreatic fluid collected.
次要结局
未报告次要终点