Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/01/2015
Date assigned
12/02/2015
Last edited
02/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 February 2018

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

Who is the main contact?
Professor Péter Hegyi
hpsg.info@gmail.com

Trial website

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

Contact information

Type

Scientific

Primary contact

Dr Peter Hegyi

ORCID ID

Contact details

University of Szeged
First Department of Medicine
Koranyi fasor 8-10
Szeged
H6720
Hungary
+36703751031
hpsg.info@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 measures

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

01/02/2018

Reason abandoned

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

15/01/2018

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

http://mta.hu/

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

Intention to publish date

15/02/2015

Participant level data

Available on request

Results - basic reporting

Publication summary

2015 protocol in http://www.ncbi.nlm.nih.gov/pubmed/26641250

Publication citations

Additional files

Editorial Notes

02/03/2016: Verifying study status with principal investigator 08/12/2015: Publication reference added.