DRUG
synthetic human secretin
Secretin is a gastrointestinal peptide hormone, indicated for the stimulation of: pancreatic secretions, including bicarbonate, to aid in the diagnosis of pancreatic exocrine dysfunction.
Status
Terminated
Phase
Phase 3
Enrollment
27
Locations
1
Results
Not posted
Publications
0
Study summary
This is a 3-year prospective study too identify the role of exocrine pancreatic insufficiency in patients with abdominal pain who are undergoing upper endoscopy. An endoscopic pancreatic function test (ePFT) with secretin will be performed in children undergoing routine investigative EGD. The goal of this study is to identify the role of exocrine pancreatic insufficiency in patients with abdominal pain who are undergoing upper endoscopy, who otherwise would be labelled as recurrent abdominal pain (RAP).
Recurrent abdominal pain (RAP) is an often encountered complaint in children and adolescents. The evaluation of the child or adolescent with recurrent abdominal pain requires an understanding of the pathogenesis of abdominal pain, the most common causes of abdominal pain, and the typical patterns of presentation. Children and adolescents frequently undergo esophagogastroduodenoscopy (EGD) to evaluate complaint and recurrent abdominal pain is a frequently cited reason for endoscopy. This is a standard procedure where an endoscope is passed through the mouth, esophagus, stomach and into the first part of the small intestine. With the camera at the end of the endoscope, the endoscopist is able to see the gross appearance of the upper digestive tract. Small biopsy samples are collected from the small intestine, stomach and esophagus to evaluate for mucosal injury, irritation, infection or other anomalies that could be contributing to the patient's symptoms. This is helpful for evaluation of histological changes, but does not provide information about its function. Pancreatic stimulation testing with secretagogue (secretin, cholecystokinin) administration, and direct pancreatic fluid collection is considered a gold standard to assess the exocrine pancreatic function. Indirect testing of pancreatic function such as with urine or stool has much lower sensitivity and specificity compared to direct pancreatic fluid collection. This is a prospective study where patients undergoing investigative EGD will have endoscopic pancreatic function test (ePFT) with secretin. There will be two groups: The first group are patients that are undergoing EGD with ePFT for evaluation of suspected or established pancreatic insufficiency with symptoms such as failure to thrive or malabsorption. These patients are the ones that historically have had ePFT testing done to evaluate their pancreatic function. The second group is all patients that are undergoing scheduled diagnostic EGD for other reasons that consent for pancreatic stimulation testing. These patients are usually undergoing EGD for a range of symptoms that frequently include recurrent abdominal pain, bloating, diarrhea, nausea and/or constipation. These patients do not typically have ePFT testing performed and is not usually thought to be part of the standard of care for this group.
Interventions
DRUG
Secretin is a gastrointestinal peptide hormone, indicated for the stimulation of: pancreatic secretions, including bicarbonate, to aid in the diagnosis of pancreatic exocrine dysfunction.
Timeline
First posted
Jan 18, 2020
Study start
Jan 28, 2022
Primary completion
Jun 15, 2023
Study completion
Jun 15, 2023
Results posted
Not reported
Registry updated
Apr 3, 2024
Outcomes
Prevalence of pancreatic insufficiency in Pediatric cases undergoing upper endoscopy for Abdominal Pain
Time frame · 2.5 years
Secretin stimulated exocrine pancreatic enzyme activity will be measured in patients with abdominal pain who are undergoing upper endoscopy to identify those with insufficiency (EPI).
Secondary biomarkers for exocrine pancreatic insufficiency in blood and pancreatic fluid will be measured to explore mechanisms involved leading to abdominal pain and become potential tests in future.
Time frame · 2.5 years
This includes immunological and genetic markers.
Eligibility
Inclusion Criteria: * For Group 1- Patients undergoing EGD with ePFT for symptoms of suspected or known pancreatic insufficiency * For Group 2- Patients undergoing diagnostic EGD who consent to undergo ePFT Exclusion Criteria: * If it is an emergency EGD procedure * If the caregiver refuses to sign the consent form * Patient has undergone ePFT testing previously with a documented allergy to human secretin * Patients that require atropine at the time of sedation
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Orlando Health - Arnold Palmer Children's Hospital
Orlando, Florida, United States
Publications
No PMID-linked publications were present in this registry snapshot.
Related trials
Mayo Clinic · Exocrine Pancreatic Insufficiency · Chronic Pancreatitis
Phase 4
Recruiting
24
2026-07
Erasmus Medical Center · Liver Transplantation
Phase 1 / Phase 2
Enrolling by invitation
20
2026-06
Children's Hospital Medical Center, Cincinnati · Pancreatitis · Diabetes Mellitus
Phase 4
Enrolling by invitation
195
2026-03
University of California, Los Angeles · Anorexia in Adolescence
Not applicable
Recruiting
10
2026-02
M.D. Anderson Cancer Center · Pancreatitis
Not applicable
Recruiting
2,345
2025-10
Johns Hopkins University · Pancreas Cancer · Peutz-Jeghers Syndrome (PJS)
Phase 3
Recruiting
9,000
2025-10
The University of Texas Health Science Center at San Antonio · Post Bariatric Surgery · Gastric Bypass
Early Phase 1
Recruiting
200
2025-09
Adenocyte, LLC · IPMN, Pancreatic · Pancreas Cancer
Not applicable
Enrolling by invitation
500
2025-03
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.