Recurrent Abdominal Pain and Exocrine Pancreatic Insufficiency

What Was Tested

This registered phase 3 trial tested Secretin.

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).

It had two arms (groups): ChiRhoStim Group 1 (active comparator) and ChiRhoStim Group 2 (experimental).

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

Patients undergoing diagnostic EGD that consent to undergo ePFT.

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

The registry lists 27 actual participants took part.

It was open to people of any sex aged from 6 months up to 18 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Secretin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2022-01-28 with completion listed for 2023-06-15.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What Was Measured

Researchers chose this as the main measure: Prevalence of pancreatic insufficiency in Pediatric cases undergoing upper endoscopy for Abdominal Pain (time frame: 2.5 years).

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Secretin in 27 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Secretin compound page, all human trials.