Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Andrea Párniczky
ORCID ID
Contact details
University of Szeged
First Department of Medicine
Koranyi fasor 8-10
Szeged
H-6720
Hungary
+36703751031
andrea.parniczky@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Analysis of Pediatric Pancreatitis (APPLE): a cohort study
Acronym
APPLE
Study hypothesis
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
National Hungarian Ethical Authority (ETT TUKEB), 26/11/2014, no. 52499-3/2014
Study design
Multicenter cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient 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.
Condition
Acute pancreatitis
Intervention
No interventions
Intervention type
Other
Phase
Drug names
Primary outcome measures
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.
Secondary outcome measures
N/A
Overall trial start date
01/02/2015
Overall trial end date
31/03/2020
Reason abandoned
Eligibility
Participant inclusion criteria
1. Acute pancreatitis
2. Age < 18 years old
3. Presenting at the emergency department of a hospital
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
300
Participant exclusion criteria
Age > 18 years old
Recruitment start date
15/02/2015
Recruitment end date
31/12/2019
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, Turkey, Ukraine, United Kingdom, United States of America
Trial participating centre
University of Szeged
Koranyi fasor 8-10
Szeged
H-6720
Hungary
Trial participating centre
Leipzig University
Liebigstrasse 20
Leipzig
D-04103
Germany
Sponsor information
Organisation
Hungarian Academy of Sciences
Sponsor details
SZTE MTA Lendulet Translational Gastrointestinal Research Group
8-10 Koranyi fasor
Szeged
H-6720
Hungary
+3662545200
hegyi.peter@med.u-szeged.hu
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Hungarian Pancreatic Study Group
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
International Scientific Journals The prestudy protocol was published in November 2016 in Digestion:
https://www.ncbi.nlm.nih.gov/pubmed/26613586
Intention to publish date
31/05/2020
Participant level data
Available on request
Results - basic reporting
Publication summary
2015 protocol in http://www.ncbi.nlm.nih.gov/pubmed/26613586