Recurrent Abdominal Pain and Exocrine Pancreatic Insufficiency

Phase 3

Terminated

• Conditions: Irritable Bowel Syndrome; Abdominal Pain
• Interventions: Drug: synthetic human secretin

• Registration Number: NCT04231279
• Lead Sponsor: Orlando Health, Inc.

Brief 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).

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-01-09
• Study First Submitted QC: 2020-01-13
• Study First Posted: 2020-01-18
• Study Start: 2022-01-28
• Primary Completion: 2023-06-15
• Study Completion: 2023-06-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ChiRhoStim Group 2	synthetic human secretin	Patients undergoing diagnostic EGD that consent to undergo ePFT.
ChiRhoStim Group 1	synthetic human secretin	Patients undergoing EGD with ePFT for symptoms of suspected or known pancreatic insufficiency.

Primary Outcome Measures

Name	Time	Method
Prevalence of pancreatic insufficiency in Pediatric cases undergoing upper endoscopy for Abdominal Pain	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 Outcome Measures

Name	Time	Method
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.	2.5 years	This includes immunological and genetic markers.

Trial Locations

Locations (1)

Orlando Health - Arnold Palmer Children's Hospital; 🇺🇸 Orlando, Florida, United States