ISRCTN ISRCTN89664974
DOI https://doi.org/10.1186/ISRCTN89664974
Secondary identifying numbers N/A
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

Study website

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

Study designMulticenter cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet The multicenter, clinical APPLE study is aimed at pediatric patients with pancreatitis. The study protocol is suitable for tracking both newly diagnosed (APPLE-P, prospective analysis) and earlier episodes (APPLE-R, retrospective analysis) of pancreatitis. There is little information available on pediatric pancreatitis. The incidence of pediatric pancreatitis has increased in the past 10 years. According to our current knowledge, the occurrence of genetic risk factors in pediatric pancreatitis could be significantly, even 10 times higher, than in adults. Also, we know that the role of alcohol is insignificant in etiology. Children having acute pancreatitis are probably going to have recurrent episodes that eventually may lead to chronic pancreatitis. Except for etiology, we have little information on the development of the disease and its effect on life quality. The early assessment of severity is crucial in the management of the disease. Current methods of risk stratification have a limited value, as they are difficult, mainly based on invasive measurement techniques and provide relatively little additional information, thus may delay appropriate management. There is a need for new clinical methods that help to improve the accuracy of early evaluation of severity in acute pancreatitis. We assume, with early recognition of severe disease, doctors will have more possibilities to intervene to prevent serious adverse events and improve the overall clinical outcome. You can help in getting to know the disease better by joining the APPLE study.
Scientific titleAnalysis of Pediatric Pancreatitis (APPLE): a cohort study
Study acronymAPPLE
Study objectives1. 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) studiedAcute pancreatitis
InterventionNo interventions
Intervention typeOther
Primary outcome measure1. 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.
Secondary outcome measuresN/A
Overall study start date01/02/2015
Completion date31/03/2022

Eligibility

Participant type(s)Patient
Age groupChild
Upper age limit18 Years
SexBoth
Target number of participants300
Key inclusion criteria1. Acute pancreatitis
2. Age < 18 years old
3. Presenting at the emergency department of a hospital
Key exclusion criteriaAge > 18 years old
Date of first enrolment15/02/2015
Date of final enrolment31/12/2021

Locations

Countries of recruitment

  • 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 Kingdom
  • 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

Sponsor information

Hungarian Academy of Sciences
Research organisation

SZTE MTA Lendulet Translational Gastrointestinal Research Group
8-10 Koranyi fasor
Szeged
H-6720
Hungary

Phone +3662545200
Email hegyi.peter@med.u-szeged.hu
Website http://mta.hu/
ROR logo "ROR" https://ror.org/02ks8qq67

Funders

Funder type

Research organisation

Hungarian Pancreatic Study Group

No information available

Results and Publications

Intention to publish date31/05/2022
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planInternational Scientific Journals The prestudy protocol was published in November 2016 in Digestion:
https://www.ncbi.nlm.nih.gov/pubmed/26613586
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 01/06/2016 Yes No

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.