Current partner codePEPTIDESDE
NCT04231279·Phase 3·INTERVENTIONAL

Recurrent Abdominal Pain and Exocrine Pancreatic Insufficiency

Status

Terminated

Phase

Phase 3

Enrollment

27

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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).

Full 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.

Interventions

Treatment arms and agents.

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.

Timeline

From registration to results.

  1. First posted

    Jan 18, 2020

  2. Study start

    Jan 28, 2022

  3. Primary completion

    Jun 15, 2023

  4. Study completion

    Jun 15, 2023

  5. Results posted

    Not reported

  6. Registry updated

    Apr 3, 2024

Outcomes

What the study measures.

Primary 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 outcomes

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

Who can take part.

Minimum age
6 Months
Maximum age
18 Years
Sex
ALL
Healthy volunteers
No

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

1 registered sites.

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

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Secretin.

Related PeptideStat pages

Put the record in context.

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