Plain English Summary
Background and study aims
The incidence of pancreatitis in children has increased in the past 10 years and the reasons are unclear. According to the two major studies in the USA and Australia, 3.6 and 13.2 children in 100,000 have the disease, which proves that pancreatitis is not rare among children. A retrospective trial in Pittsburgh, Pennsylvania (USA), suggests a close relation between the number of serum amylase and lipase measurements and the rising incidence of the disease, which suggests that pancreatitis in children is an underdiagnosed disease. The aim in this study is to explore the path from the first sign of abdominal pain to the diagnosis of pancreatitis.
Who can participate?
Children with abdominal pain attending the emergency department of a hospital.
What does the study involve?
Patients will be followed up until the diagnosis of pancreatitis.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
1. University of Szeged (Hungary)
2. Leipzig University (Germany)
When is the study starting and how long is it expected to run for?
February 2015 to March 2020
Who is funding the study?
Hungarian Pancreatic Study Group (Hungary)
Who is the main contact?
Dr Peter Hegyi
hpsg.info@gmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Dóra Mosztbache
ORCID ID
Contact details
University of Szeged
First Department of Medicine
Koranyi fasor 8-10
Szeged
H6720
Hungary
+36703751031
dora.mosztbacher@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Pain IN EArly phase of Pediatric Pancreatitis (PINEAPPLE) trial: a cohort study
Acronym
PINEAPPLE
Study hypothesis
1. To explore the route from the first sign of abdominal pain to the diagnosis of pancreatitis in a retrospective (PINEAPPLE-R) and prospective (PINEAPPLE-P) data collection methods:
1.1. PINEAPPLE-R: to look into the diagnostical practice by overviewing 1-month patient flows of medical and surgical emergency units
1.2. PINEAPPLE-P: to provide a fast, simple and authentic scoring system that helps to evaluate (in a reliable and cost-efficient way) the necessity of pancreatic enzyme test and abdominal ultrasonography or computed tomography when a child has abdominal pain
2. Hypothesis: the number of serum amylase and lipase measurements correlate with the incidence of the disease; the assumption is that the incidence will decrease from western to eastern Europe
Ethics approval
National Hungarian Ethical Authority (ETT TUKEB), 26/11/2014, no. 52857-3/2014
Study design
Multicentre observational clinical study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
PINEAPPLE is a clinical trial, which we welcome your institute to join. The trial protocol aims to explore the route from the first sign of abdominal pain to the diagnosis of pancreatitis in a retrospective (PINEAPPLE-R) and a prospective (PINEAPPLE-P) way. There is little information available in publications on pediatric pancreatitis. According to the two major studies in the USA and Australia surveying the incidence of pediatric pancreatitis, 3.6 and 13.2 in 100.000 children have the disease, which proves that pancreatitis is not a rare disease among children. The incidence of pediatric pancreatitis has increased in the past 10 years and the reasons are unclear yet. A retrospective trial in Pittsburgh (USA) suggests a close relation between the number of serum amylase and lipase measurements and the incidence of the disease, which raises the possibility of pediatric pancreatitis being an underdiagnosed disease. Pediatric pancreatitis is an especially rarely diagnosed disease in Central and Eastern Europe. The aim of this trial is to retrospectively look into our diagnostical practice (PINEAPPLE-R), and to provide a fast, simple and authentic value system that helps to evaluate (in a reliable and cost efficient way) the necessity of pancreatic enzyme test and abdominal ultrasonography or computed tomography when a child has abdominal pain. We initiated our prospective trial (PINEAPPLE-P) to accurately measure these parameters.
Condition
Alarming signs of pancreatitis
Intervention
No interventions
Intervention type
Other
Phase
Drug names
Primary outcome measure
Scoring system to evaluate (in a reliable and cost efficient way) the necessity of pancreatic enzyme testing and abdominal ultrasonography or computed tomography when a child has abdominal pain: patient data will be assessed every 3 months, with investigation of what are the most common clinical characteristics (including anamnestic information, vomiting, localisation/intensity of pain, fever and body-mass index) for acute pancreatitis.
Secondary outcome measures
N/A
Overall trial start date
01/02/2015
Overall trial end date
31/03/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Abdominal pain
2. Age < 18 years old
3. Attending hospital emergency department
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
20,000
Participant exclusion criteria
1. No abdominal pain
2. 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
H6720
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
H6720
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
Planned publication in international scientific journals. The prestudy protocol was published in December 2016 in Digestion: https://www.ncbi.nlm.nih.gov/pubmed/26641250
Intention to publish date
31/05/2020
Participant level data
Available on request
Basic results (scientific)
Publication list
2015 protocol in http://www.ncbi.nlm.nih.gov/pubmed/26641250
2015 protocol in https://www.ncbi.nlm.nih.gov/pubmed/26114177