Analysis of Pediatric Pancreatitis - APPLE trial

ISRCTN	ISRCTN89664974
DOI	https://doi.org/10.1186/ISRCTN89664974
Protocol serial number	N/A
Sponsor	Hungarian Academy of Sciences
Funder	Hungarian Pancreatic Study Group

Submission date: 27/01/2015
Registration date: 12/02/2015
Last edited: 07/01/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
In the past few years, the incidence of pancreatitis in children has risen. The assessment of severity is crucial for the management of the disease. The available scoring systems to predict severity in adults have limitations when applied to children. Early recognition of severe disease might prevent serious adverse events and improve management and overall outcome for patients. The aim in this study is to establish a simple, easy and accurate clinical scoring system for early prediction of acute pancreatitis in children.

Who can participate?
Children presenting with pancreatitis in the emergency department of a hospital

What does the study involve?
Simple potential prognostic parameters will be obtained at admission (or not later than 6–12 hours afterwards) from children diagnosed with acute pancreatitis to assess their correlation with the disease severity.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
University of Szeged (Hungary) and Leipzig University (Germany)

When is the study starting and how long is it expected to run for?
February 2015 to February 2018

Who is funding the study?
Hungarian Pancreatic Study Group (Hungary)

Who is the main contact?
Andrea Párniczky MD, PhD
andrea.parniczky@gmail.com

Contact information

Dr Andrea Párniczky
Scientific

University of Szeged, First Department of Medicine
Koranyi fasor 8-10
Szeged
H-6720
Hungary

Phone	+36703751031
Email	andrea.parniczky@gmail.com

Study information

Primary study design	Observational
Study design	Multicenter cohort study
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	Analysis of Pediatric Pancreatitis (APPLE): a cohort study
Study acronym	APPLE
Study objectives	1. New clinical methods are needed to help improve the accuracy of early evaluation of the severity of acute pancreatitis in children. With early recognition of severe disease, doctors might have more opportunities to intervene to prevent serious adverse events and improve the overall clinical outcome. The available scoring systems to predict severity of acute pancreatitis in adults have limitations when applied to children. DeBanto or pediatric acute pancreatitis score has a low sensitivity and is not useful for the calculation of the scores at hospitalization. 2. The APPLE trial (prospective and retrospective analysis) is designed to develop a simple and accurate clinical scoring system to stratify children with acute pancreatitis during the first 6–12 hours of hospitalization according to their risk of a severe disease course, specify the genetic background and recognize better the course of pediatric pancreatitis.
Ethics approval(s)	National Hungarian Ethical Authority (ETT TUKEB), 26/11/2014, no. 52499-3/2014
Health condition(s) or problem(s) studied	Acute pancreatitis
Intervention	No interventions
Intervention type	Other
Primary outcome measure(s)	1. Develop a simple and accurate clinical scoring system to stratify children with acute pancreatitis during the first 6–12 hours of hospitalization according to their risk of a severe disease course: simple data (e.g. medical history, physical examination, laboratory tests and diagnostic imaging ) will be collected, recorded and statistically analyzed to assess their potential correlation with the disease severity 2. Specify the genetic background: mutations in the genes PRSS1, CTRC, CPA1, CFTR and SPINK1 will be sequenced 3. Recognize better the course of the pediatric pancreatitis Data will be analyzed at 3 months.
Key secondary outcome measure(s)	N/A
Completion date	31/03/2022

Eligibility

Participant type(s)	Patient
Age group	Child
Upper age limit	18 Years
Sex	All
Target sample size at registration	300
Key inclusion criteria	1. Acute pancreatitis 2. Age < 18 years old 3. Presenting at the emergency department of a hospital
Key exclusion criteria	Age > 18 years old
Date of first enrolment	15/02/2015
Date of final enrolment	31/12/2021

Locations

Countries of recruitment

United Kingdom
Belarus
Bosnia and Herzegovina
Czech Republic
Estonia
Finland
Germany
Hungary
Italy
Latvia
Moldova
Poland
Romania
Russian Federation
Serbia
Slovakia
Slovenia
Spain
Sweden
Türkiye
Ukraine
United States of America

Study participating centres

University of Szeged

Koranyi fasor 8-10
Szeged
H-6720
Hungary

Leipzig University

Liebigstrasse 20
Leipzig
D-04103
Germany

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	01/06/2016		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

07/01/2020: The following changes have been made:
1. The recruitment end date has been changed from 31/12/2019 to 31/12/2021.
2. The overall trial end date has been changed from 31/03/2020 to 31/03/2022.
3. The intention to publish date has been changed from 31/05/2020 to 31/05/2022.
20/02/2018: The overall trial end date has been updated from 01/02/2018 to 31/03/2020. The recruitment end date has been updated from 15/01/2018 to 31/12/2019. The intention to publish date has been updated from 15/02/2015 to 31/05/2020. The PI has been updated from Professor Péter Hegyi
hpsg.info@gmail.com to Andrea Párniczky MD, PhD e-mail: andrea.parniczky@gmail.com.
01/12/2015: Publication reference added.
On 03/12/2015 the overall trial end date was changed from 01/02/2015 to 01/02/2018.