Analysis of Pediatric Pancreatitis (APPLE Trial): Pre-Study Protocol of a Multinational Prospective Clinical Trial

Andrea Párniczky, Dóra Mosztbacher, Fanni Zsoldos, Anna Tóth, Natália Lásztity, P. Hegyi

Research output: Contribution to journalArticle

10 Citations (Scopus)

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. Summary: 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. Key Message: This is the first worldwide study tracking earlier (APPLE-R) and ongoing episodes (APPLE-P) of pancreatitis.

Original languageEnglish
Pages (from-to)95-100
Number of pages6
JournalDigestion
DOIs
Publication statusAccepted/In press - Nov 26 2015

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Pancreatitis
Clinical Trials
Pediatrics
Physical Examination
Registries
Biomedical Research
Therapeutics

Keywords

  • Acute pancreatitis
  • Evidence-based medicine#
  • Genetic mutations
  • Pediatric pancreatitis

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Analysis of Pediatric Pancreatitis (APPLE Trial) : Pre-Study Protocol of a Multinational Prospective Clinical Trial. / Párniczky, Andrea; Mosztbacher, Dóra; Zsoldos, Fanni; Tóth, Anna; Lásztity, Natália; Hegyi, P.

In: Digestion, 26.11.2015, p. 95-100.

Research output: Contribution to journalArticle

Párniczky, Andrea ; Mosztbacher, Dóra ; Zsoldos, Fanni ; Tóth, Anna ; Lásztity, Natália ; Hegyi, P. / Analysis of Pediatric Pancreatitis (APPLE Trial) : Pre-Study Protocol of a Multinational Prospective Clinical Trial. In: Digestion. 2015 ; pp. 95-100.
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