Recurrent Abdominal Pain and Exocrine Pancreatic Insufficiency

NCT ID: NCT04231279

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-28
• Study Completion Date: 2023-06-15

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.

Conditions

Abdominal Pain; Irritable Bowel Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

ChiRhoStim Group 1

Patients undergoing EGD with ePFT for symptoms of suspected or known pancreatic insufficiency.

Group Type: ACTIVE_COMPARATOR

synthetic human secretin

Intervention Type: 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.

ChiRhoStim Group 2

Patients undergoing diagnostic EGD that consent to undergo ePFT.

Group Type: EXPERIMENTAL

synthetic human secretin

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

ChiRhoStim

Eligibility Criteria

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ChiRhoClin, Inc.

INDUSTRY

Sponsor Role: collaborator

Orlando Health, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Devendra Mehta

Director, Pediatric Gastroenterology Laboratory, Arnold Palmer Hospital for Children

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Orlando Health - Arnold Palmer Children's Hospital

Orlando, Florida, United States

Countries

United States

Other Identifiers

1804804

Identifier Type: OTHER

Identifier Source: secondary_id

RAP and EPI

Identifier Type: -

Identifier Source: org_study_id