Analysis of Pediatric Pancreatitis - APPLE trial

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

http://pancreas.hu/en/studies/apple

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

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

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 measure

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

31/03/2022

Reason abandoned (if study stopped)

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

31/12/2021

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

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

http://mta.hu/

Funder type

Research organisation

Funder name

Hungarian Pancreatic Study Group

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

31/05/2022

Participant level data

Available on request

Basic results (scientific)

Publication list

2015 protocol in http://www.ncbi.nlm.nih.gov/pubmed/26613586

Publication citations

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.