试验雷达 AI | ||
|---|---|---|
临床试验 NCT07285863 针对外分泌性胰腺功能不全，慢性胰腺炎目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
一个试验符合筛选条件
卡片视图
返回搜索
妙佑医疗国际A Study Of Effect Of Secretin For In Injection (Chirostim) On Pancreatic Fluid Composition In Healthy Subjects IV期 24
临床试验详情主要以英语提供。然而，试验雷达 AI可以提供帮助！只需点击“试验详解”即可查看和讨论您选择的语言的试验信息。
临床试验NCT07285863旨在研究其他，主要针对外分泌性胰腺功能不全，慢性胰腺炎。这是一项IV期 干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2026年2月1日开始，预计招募24名患者。该研究由妙佑医疗国际主导，计划于2028年1月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年2月5日。
简要概括
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.
官方标题
An Open-Label Study On The Effects Of Human Secretin For Injection (CHIROSTIM) On Pancreatic Fluid Composition In Normal Human Volunteer Participants
疾病
外分泌性胰腺功能不全慢性胰腺炎其他研究标识符
- 25-011644
NCT编号
实际开始日期
2026-02
最近更新发布
2026-02-05
预计完成日期
2028-01
计划入组人数
24
研究类型
干预性研究
试验分期 (阶段)
IV期
试验状态
尚未招募
关键词
pancreatic function test
Pancreatic fluid composition
Pancreatic fluid composition
主要目的
其他
分配方式
不适用
干预模型
单组试验
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性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 m...显示更多 | Secretin (human synthetic) - ChiRhoClin During endoscopic ultrasound (EUS), a dose of intravenous secretin (0.2 µg/kg) will be administered over the course of 1 minute to stimulate pancreatic ductal cells to secrete pancreas fluid.
Duodenal fluid will be aspirated through the echoendoscope in 5 minute increments (5, 10, 15, and 20 minutes) after the secretin has been administered |
主要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Pancreatic Fluid Bicarbonate Composition | A primary outcome will be the bicarbonate level (milliequivalent per liter) in the pancreatic fluid collected. | 5, 10, 15, and 20-minutes post-secretin administration |
Pancreatic Fluid Sodium Composition | A primary outcome will be the sodium level (milliequivalent per liter) in the pancreatic fluid collected. | 5, 10, 15, and 20-minutes post-secretin administration |
Pancreatic Fluid Potassium Composition | A primary outcome will be the potassium level (milliequivalent per liter) in the pancreatic fluid collected. | 5, 10, 15, and 20-minutes post-secretin administration |
Pancreatic Fluid Chloride Composition | A primary outcome will be the chloride level (milliequivalent per liter) in the pancreatic fluid collected. | 5, 10, 15, and 20-minutes post-secretin administration |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
接受健康志愿者
是
- Males or non-pregnant females
- Age 18-80.
- 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
- 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)
妙佑医疗国际ChiRhoClin, Inc.研究责任方
Samuel Han, 主要研究者, Principal Investigator, Mayo Clinic
研究中心联系人
联系人: Liz Lemke, 507-266-3317, [email protected]
联系人: Samuel Han, MD, [email protected]
1 位于 1 个国家/地区的研究中心
Minnesota
Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States