Secretin for Pancreatic Function Study
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called secretin, a hormone, to observe its effects on the pancreas in healthy individuals. Researchers aim to collect pancreatic fluid after administering secretin to gain insights into its function. Participants must be in good health and undergoing an endoscopic ultrasound for reasons unrelated to the pancreas. The study seeks to enhance understanding of normal pancreatic function, potentially aiding future treatments for pancreas-related issues. As a Phase 4 trial, this research explores how the already FDA-approved and effective treatment benefits a broader patient population.
Do I need to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but it does exclude people who regularly use anticholinergics (a type of medication that blocks certain nerve impulses). It's best to discuss your specific medications with the trial team.
What is the safety track record for Secretin?
Research has shown that secretin, the treatment under study, is generally safe for people. Secretin helps the pancreas produce fluid and has been safely used in various medical situations.
In one study, secretin was well-tolerated during a procedure to collect pancreatic fluid in children, with no serious side effects reported. Another study found that about 9.8% of cases experienced mild pancreatitis when secretin was used, but these cases were mild and manageable.
The FDA has already approved secretin for other uses, suggesting its general safety. Overall, evidence indicates that secretin is a safe option for the procedure being studied in this trial.12345Why are researchers enthusiastic about this study treatment?
Most treatments for pancreatic function issues focus on enzyme replacement or dietary changes. However, secretin is unique because it directly stimulates the pancreas to release digestive fluids, providing a more natural approach to assessing pancreatic health. Researchers are excited about secretin because it offers a non-invasive way to evaluate pancreatic function during an endoscopic ultrasound, potentially leading to quicker and more accurate diagnoses. This could be a game-changer in managing pancreatic health, offering insights that current standard treatments can't provide.
What evidence suggests that secretin is effective for pancreatic function?
Research shows that secretin can help assess pancreatic function by increasing the flow of pancreatic fluid. This aids in studying the pancreas's activity. One study demonstrated that using secretin in imaging helped measure this fluid, indicating its potential to evaluate pancreatic health. Another study found secretin to be a promising noninvasive method for checking how the pancreas releases digestive juices. Overall, secretin has proven effective in examining the pancreas. Participants in this trial will receive a standard dose of intravenous human secretin during an endoscopic ultrasound to assess pancreatic function.678910
Who Is on the Research Team?
Samuel Han, MD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for healthy individuals who can undergo a procedure to collect pancreatic fluid after stimulation with a drug called human secretin. Specific eligibility details are not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a standard dose of intravenous human secretin during an endoscopic ultrasound, and pancreatic fluid is collected at specified intervals
Follow-up
Participants are monitored for any immediate adverse effects following the procedure
What Are the Treatments Tested in This Trial?
Interventions
- Secretin
Trial Overview
The study is testing the effect of Secretin (human synthetic) on pancreatic fluid composition in healthy subjects, using an endoscopic method to collect the fluid after drug-induced stimulation.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
ChiRhoClin, Inc.
Industry Sponsor
Citations
The clinical value of secretin-enhanced MRCP in ...
It is proven that the volume of fluid secreted from the pancreas, in response to secretin, provides a functional analysis of its exocrine reserve. In CP, both ...
Effect of intraoperative secretin on operative outcomes in ...
Compared to placebo, intra-operative Secretin administration was not associated with an overall reduction in clinically significant pancreatic fistula formation ...
An Exocrine Pancreatic Stress Test with 11C-Acetate PET and ...
Conclusion: 11C-acetate PET studies with secretin stimulation show potential as a noninvasive method for assessing pancreatic exocrine function.
4.
clinicaltrials.gov
clinicaltrials.gov/study/NCT03686618?term=Secretin%20human%20AND%20SCT&viewType=Table&rank=1NCT03686618 | Secretin for Acute Pancreatitis
Insufficiency of electrolyte and fluid secretion by pancreatic ductal cells leads to increased patient risk for pancreatitis. Am J Gastroenterol. 2010 Sep ...
Defining the Accuracy of Secretin Pancreatic Function ...
The PPV of the secretin stimulation test in diagnosing subsequent imaging or pathology-proven chronic pancreatitis was 45 %, with a NPV of 97 % ...
Endoscopic Pancreas Fluid Collection: Methods and ...
Endoscopic collection of pancreatic fluid is safe and relatively straightforward, permitting opportunities for longitudinal analysis of these ...
7.
chirhoclin.com
chirhoclin.com/wp-content/uploads/2023/05/Pediatrics-Safety_of_Secretin_Administration_in_Children-Horvath-2016.pdfSafety of Secretin Administration in Children
On the basis of these data, the collections of pancreatic fluid should be completed within 10 minutes after the administration of the secretagogues. None of ...
PORCINE SECRETIN for injection Label - accessdata.fda.gov
The primary action of secretin is to stimulate pancreatic ductal cells to secrete pancreas fluid in large volumes that contain bicarbonate. Secretin is a ...
9.
naspghan.org
naspghan.org/wp-content/uploads/2021/01/Endoscopic_Pancreatic_Function_Testing__ePFT__in.30.pdfEndoscopic Pancreatic Function Testing (ePFT) in Children
Fluid for bicarbonate analysis does not need to be collected on ice (nor is it adversely affected if it is); however the container should be tightly sealed to ...
Efficacy and Safety of Pancreatic Juice Cytology with ...
Synthetic secretin loading improved the sensitivity of PJC from 50.0% to 70.8%. Complications included 13 (9.8%) cases of mild pancreatitis, 1 ( ...
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