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      About Digestion: 3.0 Impact Factor I 7.9 CiteScore I 0.891 Scimago Journal & Country Rank (SJR)

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      Pain in the Early Phase of Pediatric Pancreatitis (PINEAPPLE Trial): Pre-Study Protocol of a Multinational Prospective Clinical Trial

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          Abstract

          Background: There are unexpectedly large differences between the incidences of acute pancreatitis (AP) as indicated by different hospitals. Retrospective studies suggest that the reason behind this is the large differences that exist between the local managements of abdominal pain at emergency units. Unfortunately, no evidence-based medicine (EBM) guidelines are available to give proper instruction concerning the necessity of serum pancreatic enzyme measurement during abdominal pain. Summary: Pain in Early Phase of Pediatric Pancreatitis (PINEAPPLE) is an observational, multinational observational clinical trial to explore the route from the first sign of abdominal pain to the diagnosis of pancreatitis (PINEAPPLE trial). The PINEAPPLE-R subtrial is a retrospective review on the records of children (patients under 18) appearing at emergency units - a review of their clinical symptoms, results of imaging examinations and laboratory parameters. The PINEAPPLE-P subtrial is a prospective trial designed to develop a fast and simple EBM guideline that helps to evaluate (in a reliable and cost-efficient way) the necessity of pancreatic enzyme test and abdominal ultrasonography (or even computed tomography) when a child has abdominal pain. The trial has been registered at the ISRCTN registry and has received the relevant ethical approval. Key Message: The PINEAPPLE trial will help to recognize AP in children in a highly efficient manner.

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          Most cited references24

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          Definitions of pediatric pancreatitis and survey of present clinical practices.

          There is limited literature on acute pancreatitis (AP), acute recurrent pancreatitis (ARP), and chronic pancreatitis (CP) in children. The International Study Group of Pediatric Pancreatitis: In Search for a Cure (INSPPIRE) consortium was formed to standardize definitions, develop diagnostic algorithms, investigate disease pathophysiology, and design prospective multicenter studies in pediatric pancreatitis. Subcommittees were formed to delineate definitions of pancreatitis, and a survey was conducted to analyze present practice. AP was defined as requiring 2 of the following: abdominal pain compatible with AP, serum amylase and/or lipase values ≥3 times upper limits of normal, and imaging findings of AP. ARP was defined as ≥2 distinct episodes of AP with intervening return to baseline. CP was diagnosed in the presence of typical abdominal pain plus characteristic imaging findings, or exocrine insufficiency plus imaging findings, or endocrine insufficiency plus imaging findings. We found that children with pancreatitis were primarily managed by pediatric gastroenterologists. Unless the etiology was known, initial investigations included serum liver enzymes, triglycerides, calcium, and abdominal ultrasound. Further investigations (usually for ARP and CP) included magnetic resonance or other imaging, sweat chloride, and genetic testing. Respondents' future goals for INSPPIRE included determining natural history of pancreatitis, developing algorithms to evaluate and manage pancreatitis, and validating diagnostic criteria. INSPPIRE represents the first initiative to create a multicenter approach to systematically characterize pancreatitis in children. Future aims include creation of patient database and biologic sample repository.
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            Increasing incidence of acute pancreatitis at an American pediatric tertiary care center: is greater awareness among physicians responsible?

            Studies show an increased incidence of adult acute pancreatitis (AP) in recent decades. The aim was to review pediatric AP incidence. Retrospective review of computerized databases at the Children's Hospital of Pittsburgh from 1993 to 2004. The International Classification of Diseases, Ninth Revision, code 5770 Acute Pancreatitis was used; results were tabulated by discharge year and month. The incidence of AP was compared with orders for amylase and lipase testings and with the catchment population. Over the study period, there were a total of 1021 discharge diagnoses of AP (731 first diagnoses). The diagnosis of AP increased from a low of 28 total cases (21 first diagnoses) in 1993 to a high of 141 total cases (109 first diagnoses) in 2004. The catchment population decreased from 882,000 to 826,500. The estimated incidences of first AP admission were 2.4 to 13.2 per 100,000 children (years 1993-2004; r = 0.8339). Linear regression analysis suggests that increased testing for amylase and lipase could account for 94% of the change in all AP admissions (P = 5.1 x 10). The increased incidence of AP at the Children's Hospital of Pittsburgh from 1993 to 2004 may have been primarily driven by increased testing for the disease.
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              What have we learned about acute pancreatitis in children?

              Pediatric pancreatitis has received much attention during the past few years. Numerous reports have identified an increasing trend in the diagnosis of acute pancreatitis in children and key differences in disease presentation and management between infants and older children. The present review provides a brief, evidence-based focus on the latest progress in the clinical field. It also poses important questions for emerging multicenter registries to answer about the natural history and management of affected children with pancreatitis.
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                Author and article information

                Journal
                DIG
                Digestion
                10.1159/issn.0012-2823
                Digestion
                S. Karger AG
                0012-2823
                1421-9867
                2016
                March 2016
                04 December 2015
                : 93
                : 2
                : 121-126
                Affiliations
                a1st Department of Medicine, University of Szeged, MTA-SZTE Momentum Translational Gastroenterology Research Group, and bDepartment of Pediatrics, University of Szeged, Szeged, cHeim Pál Children's Hospital, Budapest, Hungary, dBalassa János Hospital Country of Tolna, Szekszárd, Hungary, and eDepartment of Pediatrics, Paracelsus Medical University, Salzburg, Austria
                Author notes
                *Péter Hegyi, MD, PhD, DSc, Professor of Medicine, 1st Department of Medicine, University of Szeged Korányi fasor 8, 6720 Szeged (Hungary), E-Mail hegyi.peter@med.u-szeged.hu
                Article
                441352 Digestion 2016;93:121-126
                10.1159/000441352
                26641250
                fc853385-fe64-4b56-9138-98a283151256
                © 2015 S. Karger AG, Basel

                Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

                History
                : 03 July 2015
                : 28 September 2015
                Page count
                Tables: 1, References: 30, Pages: 6
                Categories
                Original Paper

                Oncology & Radiotherapy,Gastroenterology & Hepatology,Surgery,Nutrition & Dietetics,Internal medicine
                Pancreatic enzyme,Pediatric pancreatitis,Acute pancreatitis,Abdominal pain,Evidence-based medicine

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