Secretin injection effects on pancreatic fluid in healthy adults
An Open-Label Study On The Effects Of Human Secretin For Injection (CHIROSTIM) On Pancreatic Fluid Composition In Normal Human Volunteer Participants
This test gives a synthetic secretin injection (ChiRhoClin) to healthy adults undergoing endoscopic ultrasound to see if it changes what’s in pancreatic fluid.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT07285863 on ClinicalTrials.gov |
What this trial studies
Healthy adults undergoing an endoscopic ultrasound for a non-pancreatic reason receive an injection of human synthetic secretin (ChiRhoClin). Pancreatic fluid is collected from the duodenum using an endoscopic pancreas function collection method after secretin stimulation. Samples will be analyzed to characterize changes in pancreatic fluid composition following stimulation. Participants are screened to exclude anyone with pancreatic disease, altered upper GI anatomy, liver disease, pregnancy or regular tobacco/alcohol/anticholinergic use.
Who should consider this trial
Good fit: Ideal candidates are healthy men or non-pregnant women age 18–80 who are scheduled for an endoscopic ultrasound for a non-pancreatic indication, are ASA class 3 or below, and meet the trial's exclusion criteria (non-smokers, limited alcohol, no pancreatic or major GI surgery, no liver disease).
Not a fit: Patients with a history of pancreatitis or other pancreatic disease, inflammatory bowel disease, prior vagotomy or altered upper GI anatomy, liver disease, pregnancy or nursing, regular anticholinergic use, smoking, or heavy alcohol use are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could improve understanding of pancreatic secretions and help refine diagnostic tests for pancreatic exocrine function.
How similar studies have performed: Secretin-stimulated pancreatic secretion testing and duodenal fluid collection are established techniques used in clinical and research settings, so the approach is not novel but aims to add specific compositional data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * 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 Exclusion Criteria * 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)
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Samuel Han, MD — Mayo Clinic
- Study coordinator: Liz Lemke
- Email: Lemke.Elizabeth@mayo.edu
- Phone: 507-266-3317
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.