Márta Katalin, Szabó Anikó N, Pécsi Dániel, Varjú Péter, Bajor Judit, Gódi Szilárd, Sarlós Patrícia, Mikó Alexandra, Szemes Kata, Papp Mária, Tornai Tamás, Vincze Áron, Márton Zsolt, Vincze Patrícia A, Lankó Erzsébet, Szentesi Andrea, Molnár Tímea, Hágendorn Roland, Faluhelyi Nándor, Battyáni István, Kelemen Dezső, Papp Róbert, Miseta Attila, Verzár Zsófia, Lerch Markus M, Neoptolemos John P, Sahin-Tóth Miklós, Petersen Ole H, Hegyi Péter
Institute for Translational Medicine, University of Pécs, Pecs, Hungary.
1st Department of Internal Medicine, University of Pécs, Pécs, Hungary.
BMJ Open. 2017 Sep 14;7(9):e015874. doi: 10.1136/bmjopen-2017-015874.
Acute pancreatitis (AP) is an inflammatory disease with no specific treatment. Mitochondrial injury followed by ATP depletion in both acinar and ductal cells is a recently discovered early event in its pathogenesis. Importantly, preclinical research has shown that intracellular ATP delivery restores the physiological function of the cells and protects from cell injury, suggesting that restoration of energy levels in the pancreas is therapeutically beneficial. Despite several high quality experimental observations in this area, no randomised trials have been conducted to date to address the requirements for energy intake in the early phase of AP.
METHODS/DESIGN: This is a randomised controlled two-arm double-blind multicentre trial. Patients with AP will be randomly assigned to groups A (30 kcal/kg/day energy administration starting within 24 hours of hospital admission) or B (low energy administration during the first 72 hours of hospital admission). Energy will be delivered by nasoenteric tube feeding with additional intravenous glucose supplementation or total parenteral nutrition if necessary. A combination of multiorgan failure for more than 48 hours and mortality is defined as the primary endpoint, whereas several secondary endpoints such as length of hospitalisation or pain will be determined to elucidate more detailed differences between the groups. The general feasibility, safety and quality checks required for high quality evidence will be adhered to.
The study has been approved by the relevant organisation, the Scientific and Research Ethics Committee of the Hungarian Medical Research Council (55961-2/2016/EKU). This study will provide evidence as to whether early high energy nutritional support is beneficial in the clinical management of AP. The results of this trial will be published in an open access way and disseminated among medical doctors.
The trial has been registered at the ISRCTN (ISRTCN 63827758).
急性胰腺炎（AP）是一种尚无特异性治疗方法的炎症性疾病。腺泡细胞和导管细胞中线粒体损伤继而导致ATP耗竭是其发病机制中最近发现的早期事件。重要的是，临床前研究表明，细胞内ATP递送可恢复细胞的生理功能并保护细胞免受损伤，这表明恢复胰腺中的能量水平具有治疗益处。尽管在该领域有多项高质量的实验观察，但迄今为止尚未进行随机试验来探讨AP早期能量摄入的需求。
方法/设计：这是一项随机对照双臂双盲多中心试验。AP患者将被随机分配至A组（入院24小时内开始给予30千卡/千克/天的能量）或B组（入院头72小时给予低能量）。能量将通过鼻肠管喂养提供，必要时额外静脉补充葡萄糖或采用全胃肠外营养。将多器官功能衰竭超过48小时和死亡率的组合定义为主要终点，而住院时间或疼痛等几个次要终点将被确定以阐明两组之间更详细的差异。将遵循高质量证据所需的一般可行性、安全性和质量检查。
该研究已获得相关组织匈牙利医学研究理事会科学与研究伦理委员会（55961-2/2016/EKU）的批准。本研究将提供证据，证明早期高能量营养支持在AP临床管理中是否有益。本试验的结果将以开放获取的方式发表并在医生中传播。
该试验已在国际标准随机对照试验编号注册库（ISRCTN 63827758）注册。
