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Research

Pain IN the EArly phase of Pediatric Pancreatitis (PINEAPPLE trial): Pre-study protocol of a multinational prospective clinical trial.

Project endorsed by IAP Council
Coordinated by: Péter Hegyi, MD, PhD, DSc

Abstract

Background: There are unexpectedly large differences between the incidences of AP among the hospitals. Retrospective studies suggesting that the reason behind this is the large differences between the local managements of abdominal pain at emergency units. Unfortunately, no evidence-based (EBM) guidelines are available to give proper instruction concerning the necessity of serum pancreatic enzyme measurement during abdominal pain.

Summary: 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 children (patients under 18) records appearing at emergency units concerning their clinical symptoms, results of imaging examinations and laboratory parameters. Whereas, 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 received the relevant ethical approval.

Key message: The PINEAPPLE trial will help to recognize AP in children with high efficiency.

Hypothesis

PINEAPPLE-R: The number of serum amylase and lipase measurement correlates with the incidence of the disease. It will decrease from Western to Eastern Europe

PINEAPPLE-P: Pediatric pancreatitis is a higly underdiagnosed disease. The PINEAPPLE trial (EBM guideline) will help to recognize AP in children with high efficiency.

Objectives

PINEAPPLE-R: Retrospectively look into our diagnostic practice by overviewing 1-month patient flows of medical and surgical emergency units.

PINEAPPLE-P: To provide a fast, simple and authentic scoring system that helps to evaluate (in a reliable and cost efficient way) the necessity of pancreatic enzyme test and abdominal ultrasonography or CT when a child has abdominal pain.

Population

The PINEAPPLE-R is a retrospective data collection, analysing one month’s patient flows of pediatric emergency and surgical units concerning the patients’ clinical symptoms, results of imaging examinations and laboratory parameters.

The PINEAPPLE-P is for patients under 18 years appearing at ER unit with a leading symptom of abdominal pain. Our aim is to collect around 100 cases from each center. Altogether we wish to collect around 20000 cases with abdominal pain within 3 years.

Inclusion Period

Sun 1 February 2015 - Thu 1 February 2018

Clinical End Points

The PINEAPPLE trial will help to recognize AP in children with high efficiency. PINEAPPLE-R study will help to understand our current clinical practice on patients with abdominal pain in different countries and centers. The PINEAPPLE-P study will help to establish an EBM guideline which will help to provide a fast, simple and authentic system to evaluate (in a reliable and cost efficient way) the necessity of pancreatic enzyme test and abdominal ultrasonography when a child has abdominal pain.

Inclusion and Exclusion Criteria

Inclusion criteria for PINEAPPLE-R

  • under 18 years old

  • accurate electronic data mentioned in the protocol

Exclusion criteria for PINEAPPLE-R
  • above 18 years old

  • inaccurate electronic data mentioned in the protocol

Inclusion criteria for PINEAPPLE-P
  • under 18 years old

  • the leading symptom is acute abdominal pain

Exclusion criteria for PINEAPPLE-P
  • above 18 years old

  • no or chronic abdominal pain

Authorship Rules

In order to give appropriate credit to each investigator/center we will use standardized authorship policy. Concerning the PINEAPPLE-R subtrial: under 1500 patients will generate 1, whereas above 1500 patients will generate maximum of 2 co-author from the center.

PINEAPPLE-P: every 100 patients will generate 1 co-author. All other investigators/contributors who do not meet the criteria for authorship will be listed in an ‘acknowledgements’ section. For example those who provide purely technical help or a department chair who provided only general support.

Other Information

All information and documents (ethical approval, protocol, letter of intent to join, patient informed consent form, questionnaire) are available in different languages on the www.pancreas.hu website.

Case Report Form Templates

Download the template using the links below and submit via email to

Or submit your Case Report Form online at:

http://

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