Pain in early phase of pediatric pancreatitis (PINEAPPLE)

ISRCTN	ISRCTN35618458
DOI	https://doi.org/10.1186/ISRCTN35618458
Protocol serial number	N/A
Sponsor	Hungarian Academy of Sciences
Funder	Hungarian Pancreatic Study Group

Submission date: 27/01/2015
Registration date: 12/02/2015
Last edited: 08/03/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Dóra Mosztbache
Scientific

University of Szeged
First Department of Medicine
Koranyi fasor 8-10
Szeged
H6720
Hungary

Phone	+36703751031
Email	dora.mosztbacher@gmail.com

Study information

Primary study design	Observational
Study design	Multicentre observational clinical study
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	Pain IN EArly phase of Pediatric Pancreatitis (PINEAPPLE) trial: a cohort study
Study acronym	PINEAPPLE
Study objectives	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(s)	National Hungarian Ethical Authority (ETT TUKEB), 26/11/2014, no. 52857-3/2014
Health condition(s) or problem(s) studied	Alarming signs of pancreatitis
Intervention	No interventions
Intervention type	Other
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	N/A
Completion date	31/03/2021

Eligibility

Participant type(s)	Patient
Age group	Child
Upper age limit	18 Years
Sex	All
Target sample size at registration	20000
Key inclusion criteria	1. Abdominal pain 2. Age < 18 years old 3. Attending hospital emergency department
Key exclusion criteria	1. No abdominal pain 2. Age > 18 years old
Date of first enrolment	15/02/2015
Date of final enrolment	31/12/2020

Locations

Countries of recruitment

United Kingdom
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 States of America

Study participating centres

University of Szeged

Koranyi fasor 8-10
Szeged
H6720
Hungary

Leipzig University

Liebigstrasse 20
Leipzig
D-04103
Germany

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	01/06/2015		Yes	No
Protocol article	protocol	01/04/2016		Yes	No
Abstract results	OP 122	01/10/2018	08/03/2023	No	No
Abstract results	OP287	01/10/2019	08/03/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Poster results	P1526	01/10/2019	08/03/2023	No	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

08/03/2023: Publication references added.
08/03/2021: The intention to publish date has been changed from 31/05/2021 to 31/12/2021.
07/01/2020: The following changes have been made:
1. The recruitment end date has been changed from 31/12/2019 to 31/12/2020.
2. The overall trial end date has been changed from 31/03/2020 to 31/03/2021.
3. The intention to publish date has been changed from 31/05/2020 to 31/05/2021.
20/02/2018: The overall trail 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 31/03/2020. The intention to publish date has been added. The PI has been changed from Dr Peter Hegyi (hpsg.info@gmail.com) to Dóra Mosztbacher MD (dora.mosztbacher@gmail.com).
02/03/2016: Verifying study status with principal investigator
08/12/2015: Publication reference added.