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Analysis of Pediatric Pancreatitis (APPLE Trial): Pre-Study Protocol of a Multinational Prospective Clinical Trial

Andrea Párniczky1, Dóra Mosztbacher, Fanni Zsoldos

  • 11st Department of Medicine, University of Szeged, MTA-SZTE Momentum Translational Gastroenterology Research Group, Szeged, Hungary.

Digestion
|November 28, 2015
PubMed

Insights

This international study, the APPLE trial, investigates acute pancreatitis (AP) in children. It aims to gather extensive clinical data and samples to understand genetic factors and improve prognosis for pediatric AP.

Area of Science:

  • Pediatric Gastroenterology
  • Clinical Research
  • Genetics

Background:

  • Single-center studies indicate a rise in pediatric acute pancreatitis (AP).
  • The Hungarian Pancreatic Study Group initiated the APPLE trial to address this.
  • A critical mass of clinical data and samples is needed for comprehensive research.

Purpose of the Study:

  • To establish an international observational clinical trial for pediatric pancreatitis.
  • To collect uniform, prospective clinical data and biomedical samples.
  • To investigate genetic variants contributing to pediatric AP and their prognostic impact.

Main Methods:

  • The APPLE trial includes two sub-trials: APPLE-R (history of pancreatitis) and APPLE-P (diagnosed AP).
  • Patients under 18 with AP meeting Atlanta criteria are selected for APPLE-P.
  • Detailed data collection includes medical history, etiology, symptoms, physical exams, labs, imaging, treatment, and complications.

Main Results:

  • The study is designed to collect a significant cohort for robust analysis.
  • It will provide insights into the genetic underpinnings of pediatric pancreatitis.
  • The collected data will inform prognostic assessments.

Conclusions:

  • The APPLE trial is the first global initiative to track both prior and ongoing pancreatitis episodes in children.
  • It establishes a framework for international collaboration in pediatric pancreatitis research.
  • Findings are expected to enhance understanding and management of AP in pediatric populations.
Abstract

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