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

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.背景：现有单中心研究显示，儿童急性胰腺炎（acute pancreatitis, AP）的发病率呈上升趋势。匈牙利胰腺研究学会儿科学分会特此推出一项国际性观察性临床试验（APPLE），以统一的前瞻性方式收集足量临床数据与生物医学研究样本。 概述：APPLE-R 针对存在胰腺炎病史的18岁以下患者，该亚试验主要旨在明确该病潜在的遗传变异及其对预后的影响。APPLE-P 针对经确诊为AP的18岁以下患者，将纳入符合亚特兰大标准“3项指标中满足2项”诊断标准的AP患儿。该亚试验需收集详尽的病史、病因、主诉与症状、体格检查结果、实验室参数、影像学资料、入院即刻治疗方案及疾病并发症相关信息。APPLE 试验已在ISRCTN注册平台完成注册，并获得相关伦理批准，本研究面向全球所有儿科中心开放。 核心要点：本研究是全球首个同时追踪胰腺炎既往发作（APPLE-R）与当前发作（APPLE-P）的研究。