Dept, of OR/Evidence Based Surgery, Radboud University Nijmegen Medical Centre, PO 9101, 6500 HB Nijmegen; The Netherlands.
Trials. 2011 Mar 10;12:73. doi: 10.1186/1745-6215-12-73.
In predicted severe acute pancreatitis, infections have a negative effect on clinical outcome. A start of enteral nutrition (EN) within 24 hours of onset may reduce the number of infections as compared to the current practice of starting an oral diet and EN if necessary at 3-4 days after admission.
METHODS/DESIGN: The PYTHON trial is a randomised controlled, parallel-group, superiority multicenter trial. Patients with predicted severe acute pancreatitis (Imrie-score ≥ 3 or APACHE-II score ≥ 8 or CRP > 150 mg/L) will be randomised to EN within 24 hours or an oral diet and EN if necessary, after 72 hours after hospital admission.During a 3-year period, 208 patients will be enrolled from 20 hospitals of the Dutch Pancreatitis Study Group. The primary endpoint is a composite of mortality or infections (bacteraemia, infected pancreatic or peripancreatic necrosis, pneumonia) during hospital stay or within 6 months following randomisation. Secondary endpoints include other major morbidity (e.g. new onset organ failure, need for intervention), intolerance of enteral feeding and total costs from a societal perspective.
The PYTHON trial is designed to show that a very early (< 24 h) start of EN reduces the combined endpoint of mortality or infections as compared to the current practice of an oral diet and EN if necessary at around 72 hours after admission for predicted severe acute pancreatitis.
ISRCTN: ISRCTN18170985.
在预测的重症急性胰腺炎中，感染对临床结局有负面影响。与目前在入院后 3-4 天开始口服饮食和必要时开始肠内营养的做法相比，在发病后 24 小时内开始肠内营养（EN）可能会减少感染的数量。
方法/设计：PYTHON 试验是一项随机对照、平行组、优效性多中心试验。预计患有重症急性胰腺炎的患者（Imrie 评分≥3 或 APACHE-II 评分≥8 或 CRP>150mg/L）将被随机分配到 24 小时内接受 EN 或在入院后 72 小时内接受口服饮食和必要时的 EN。在 3 年期间，将从荷兰胰腺炎研究组的 20 家医院招募 208 名患者。主要终点是住院期间或随机分组后 6 个月内死亡率或感染（菌血症、感染性胰腺或胰周坏死、肺炎）的复合终点。次要终点包括其他主要发病率（例如新发器官衰竭、需要干预）、肠内喂养不耐受和从社会角度考虑的总费用。
PYTHON 试验旨在表明与目前在入院后 3-4 天开始口服饮食和必要时开始肠内营养的做法相比，在预测的重症急性胰腺炎患者中，非常早期（<24 小时）开始 EN 可降低死亡率或感染的复合终点。
ISRCTN: ISRCTN86216759。
