Recurrent Abdominal Pain and Exocrine Pancreatic Insufficiency
Primary Purpose
Abdominal Pain, Irritable Bowel Syndrome
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
synthetic human secretin
Sponsored by
About this trial
This is an interventional diagnostic trial for Abdominal Pain
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
ChiRhoStim Group 1
ChiRhoStim Group 2
Arm Description
Patients undergoing EGD with ePFT for symptoms of suspected or known pancreatic insufficiency.
Patients undergoing diagnostic EGD that consent to undergo ePFT.
Outcomes
Primary Outcome Measures
Prevalence of pancreatic insufficiency in Pediatric cases undergoing upper endoscopy for Abdominal Pain
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
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.
This includes immunological and genetic markers.
Full Information
NCT ID
NCT04231279
First Posted
January 9, 2020
Last Updated
January 13, 2020
Sponsor
Orlando Health, Inc.
Collaborators
ChiRhoClin, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04231279
Brief Title
Recurrent Abdominal Pain and Exocrine Pancreatic Insufficiency
Official Title
Recurrent Abdominal Pain and Exocrine Pancreatic Insufficiency
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2020 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Orlando Health, Inc.
Collaborators
ChiRhoClin, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Pain, Irritable Bowel Syndrome
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ChiRhoStim Group 1
Arm Type
Active Comparator
Arm Description
Patients undergoing EGD with ePFT for symptoms of suspected or known pancreatic insufficiency.
Arm Title
ChiRhoStim Group 2
Arm Type
Experimental
Arm Description
Patients undergoing diagnostic EGD that consent to undergo ePFT.
Intervention Type
Drug
Intervention Name(s)
synthetic human secretin
Other Intervention Name(s)
ChiRhoStim
Intervention Description
Secretin is a gastrointestinal peptide hormone, indicated for the stimulation of: pancreatic secretions, including bicarbonate, to aid in the diagnosis of pancreatic exocrine dysfunction.
Primary Outcome Measure Information:
Title
Prevalence of pancreatic insufficiency in Pediatric cases undergoing upper endoscopy for Abdominal Pain
Description
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).
Time Frame
2.5 years
Secondary Outcome Measure Information:
Title
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.
Description
This includes immunological and genetic markers.
Time Frame
2.5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katelyn Kern, RN, BSN
Phone
321-841-9560
Email
Katelyn.Kern@orlandohealth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Devendra Mehta, MD
Organizational Affiliation
Orlando Health, Inc.
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Recurrent Abdominal Pain and Exocrine Pancreatic Insufficiency
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