Pain in early phase of pediatric pancreatitis (PINEAPPLE)
| ISRCTN | ISRCTN35618458 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35618458 |
| Secondary identifying numbers | N/A |
- 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
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
Scientific
University of Szeged
First Department of Medicine
Koranyi fasor 8-10
Szeged
H6720
Hungary
| Phone | +36703751031 |
|---|---|
| dora.mosztbacher@gmail.com |
Study information
| Study design | Multicentre observational clinical study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant 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. |
| 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 | 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 study start date | 01/02/2015 |
| Completion date | 31/03/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20,000 |
| 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
- 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 Kingdom
- United States of America
Study participating centres
Szeged
H6720
Hungary
Leipzig
D-04103
Germany
Sponsor information
Research organisation
SZTE MTA Lendulet Translational Gastrointestinal Research Group
8-10 Koranyi fasor
Szeged
H6720
Hungary
| Phone | +3662545200 |
|---|---|
| hegyi.peter@med.u-szeged.hu | |
| Website | http://mta.hu/ |
"ROR" |
https://ror.org/02ks8qq67 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 31/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 |
| 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 |
| Poster results | P1526 | 01/10/2019 | 08/03/2023 | No | No |
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.
