THIS IS A JOINT PROJECT ORGANIZED BY THE HUNGARIAN PANCREATIC STUDY GROUP AND THE

INTERNATIONAL ASSOCIATION OF PANCREATOLOGY

www.pancreas.hu

www.internationalpancreatology.org

PINEAPPLE is a clinical trial, which we welcome your institute to join. The trial protocol aimes 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 United States 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 last 10 years and the reasons are uncleared yet. A retrospective trial in Pittsburgh suggests close relationship between the number of serum amylase and lipase measurementand 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 providea 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 CT when a child has abdominal pain.

We initiated our prospective trial (PINEAPPLE-P) to accurately measure these parameters.

PINEAPPLE-Rtrial

In one certain month (e.g. in September 2014) we collect information on patients appearing with abdominal pain at emergency and surgical units, concerning their clinical symptoms, results of imaging examinations and laboratory parameters. The excel form can be downloaded from below (PINEAPPLE-R-ENG-FORM A.xls).

PINEAPPLE-P trial

Patients under 18 years appearing with abdominal pain at emergency and surgical units, can be included in the trial. This trial helps to evaluate the possibility of pancreatitis as the reason behind the abdominal pain and helps to recognise it early. The detailed examination at the first appeearance of the patient is very important. Please look at the questionnaire thoroughly in advance so as not to leave out any of the necessary examinations.

AUTHORSHIP POLICY:

PINEAPPLE-R: under 1500 patients - 1 co-author, above 1500 patients – 2 co-authors.
PINEAPPLE-P: 100 patients – 1 co-author.

Etichal approval number: ETT TUKEB ad.52857-2/2014

Registration number: ISRCTN35618458

Pre-study article: Digestion

Presentations: Studies general, PINEAPPLE

PINEAPPLE Trial Protocol	PINEAPPLE Letter of Intent to Join	PINEAPPLE Informed Consent Form
PINEAPPLE-R Form A	PINEAPPLE-P Form A	PINEAPPLE Ethical approval