title: Analysis of Pediatric Pancreatitis (APPLE Trial): Pre-Study Protocol of a Multinational Prospective Clinical Trial.
abstract: BACKGROUND
  Single-centered studies show increased number of acute pancreatitis (AP) in children. Here, the Pediatric Section of the Hungarian Pancreatic Study Group introduces an international observational clinical trial (APPLE) to collect a critical mass of clinical data and biomedical research samples in a uniform prospective manner.
  
  
  CONCLUSIONS
  The APPLE-R is for patients under 18 years of age with a history of pancreatitis. The study primarily provides information on possible genetic variants behind the disease and their impact on the prognosis. The APPLE-P is for patients under 18 years of age with a diagnosis of AP. Children with AP diagnosed based on the fulfillment of '2 out of 3' of the Atlanta criteria will be selected. This subtrial requests detailed information from the medical history, etiology, complains and symptoms, physical examinations, laboratory parameters, imaging, immediate therapy at admission and complications of the disease. The APPLE trial has been registered at the ISRCTN registry and has received the relevant ethical approval. The study is open for all pediatric centers throughout the world.
  
  
  CONCLUSIONS
  This is the first worldwide study tracking earlier (APPLE-R) and ongoing episodes (APPLE-P) of pancreatitis.
authors.affiliation: 1st Department of Medicine, University of Szeged, MTA-SZTE Momentum Translational Gastroenterology Research Group, Szeged, Hungary.
authors.forename: Andrea
authors.initials: A
authors.lastname: Párniczky
authors.forename: Dóra
authors.initials: D
authors.lastname: Mosztbacher
authors.forename: Fanni
authors.initials: F
authors.lastname: Zsoldos
authors.forename: Anna
authors.initials: A
authors.lastname: Tóth
authors.forename: Natália
authors.initials: N
authors.lastname: Lásztity
authors.forename: Péter
authors.initials: P
authors.lastname: Hegyi
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D043422:Carboxypeptidases A / Q000235:genetics; D002352:Carrier Proteins / Q000235:genetics; D002648:Child; D002675:Child, Preschool; D002908:Chronic Disease; D002918:Chymotrypsin / Q000235:genetics; D019005:Cystic Fibrosis Transmembrane Conductance Regulator / Q000235:genetics; D016002:Discriminant Analysis; D005260:Female; D006760:Hospitalization; D006801:Humans; D006814:Hungary; D007223:Infant; D007231:Infant, Newborn; D008049:Lipase / Q000235:genetics; D016015:Logistic Models; D008297:Male; D010195:Pancreatitis / Q000097:blood / Q000235:genetics* / Q000503:physiopathology / Q000628:therapy; D011379:Prognosis; D011446:Prospective Studies; D012042:Registries; D014357:Trypsin / Q000235:genetics; D014359:Trypsin Inhibitor, Kazal Pancreatic
chemical_list: C505032:CFTR protein, human; D002352:Carrier Proteins; C486642:SPINK1 protein, human; D019005:Cystic Fibrosis Transmembrane Conductance Regulator; D014359:Trypsin Inhibitor, Kazal Pancreatic; C054621:CEL protein, human; D008049:Lipase; D043422:Carboxypeptidases A; D002918:Chymotrypsin; C117569:chymotrypsin C; C489303:PRSS1 protein, human; D014357:Trypsin