Pain in the Early Phase of Pediatric Pancreatitis (PINEAPPLE Trial): Pre-Study Protocol of a Multinational Prospective Clinical Trial

Abstract

Background: There are unexpectedly large differences between the incidences of acute pancreatitis (AP) as indicated by different hospitals. Retrospective studies suggest that the reason behind this is the large differences that exist between the local managements of abdominal pain at emergency units. Unfortunately, no evidence-based medicine (EBM) guidelines are available to give proper instruction concerning the necessity of serum pancreatic enzyme measurement during abdominal pain. Summary: Pain in Early Phase of Pediatric Pancreatitis (PINEAPPLE) is an observational, multinational observational clinical trial to explore the route from the first sign of abdominal pain to the diagnosis of pancreatitis (PINEAPPLE trial). The PINEAPPLE-R subtrial is a retrospective review on the records of children (patients under 18) appearing at emergency units - a review of their clinical symptoms, results of imaging examinations and laboratory parameters. The PINEAPPLE-P subtrial is a prospective trial designed to develop a fast and simple EBM guideline that helps to evaluate (in a reliable and cost-efficient way) the necessity of pancreatic enzyme test and abdominal ultrasonography (or even computed tomography) when a child has abdominal pain. The trial has been registered at the ISRCTN registry and has received the relevant ethical approval. Key Message: The PINEAPPLE trial will help to recognize AP in children in a highly efficient manner.