Analysis of Pediatric Pancreatitis (APPLE trial): Pre-study protocol of a multinational prospective clinical trial
Home Analysis of Pediatric Pancreatitis (APPLE trial): Pre-study protocol of a multinational prospective clinical trial

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

Abstract 

Background: Single-centered studies show increased incidence of acute pancreatitis (AP) in children. Here, the Pediatric Section of the Hungarian Pancreatic Study Group introduce an international observational clinical trial (APPLE) to collect a critical mass of clinical data and biomedical research samples in a uniform prospective manner.

Summary: The APPLE-R is for patients with history of pancreatitis under 18 years old. The study primarily provides information on possible genetic variants behind the disease and their impact on the prognosis. The APPLE-P is for patients under 18 years old with a diagnosis of acute pancreatitis. Children with AP diagnosed based on the fulfillment of “2 out of 3” of the Atlanta criteria will be selected. This subtrial requests detailed information from the medical history, etiology, complains and symptoms, physical examinations, laboratory parameters, imaging, immediate therapy at admission and complications of the disease. The APPLE trial has been registered at the ISRCTN registry and received the relevant ethical approval. The study is open for all pediatric centers throughout the world.

Key message: this is the first worldwide study tracking earlier (APPLE-R) and ongoing episodes (APPLE-P) of pancreatitis.

Hypothesis 

This multicenter prospective trial helps to understand the genetic background of pediatric pancreatitis. We will be able to identify early risk factors and a scoring system to stratify patients according to severity.

Objectives 

The APPLE trials are designed to develop a simple and accurate clinical scoring system that can stratify children with AP during the first 6-12 hours of hospitalization according to their risk for severe disease course and specify the genetic background and recognize better the course of the pediatric pancreatitis.

Population 

The APPLE-R is for patients with history of pancreatitis under 18 years old. Approximately 800 patients are planned to be collected within 3 years.

The APPLE-P is for patients under 18 years old with freshly diagnosed ongoing acute pancreatitis. Approximately 300 patients are planned to be enrolled within 3 years. Patients with AP diagnosed based on the fulfillment of “2 out of 3” of the criteria (presence of abdominal pain, signs of pancreatitis on imaging, 3x elevated pancreas enzyme level) will be selected.

Inclusion Period 

Sun 1 February 2015 – Thu 1 February 2018

Clinical End Points 

The multinational observational clinical trial (APPLE) is designed to collect a critical mass of clinical data from children suffering in AP in a uniform prospective manner to help fill the knowledge gap and provide simple, pediatric-specific, clinical scoring system that can stratify patients with AP on presentation.

Inclusion and Exclusion Criteria 

APPLE-R inclusion criteria:

  • history of pancreatitis before the age of 18 years

APPLE-P inclusion criteria:

    • under 18 years old

 

  • newly diagnosed ongoing acute pancreatitis

APPLE-P Exclusion criteria:

  • above 18 years old

Authorship Rules 

In order to give appropriate credit to each investigator/center we will use standardized authorship policy. At least 5 patients are required for a co-authorship. 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, questionnaires) 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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