Early Enteral vs. Oral Nutrition After Whipple Procedure: a Multicentric Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 3
- 主要终点
- Comprehensive Complication Index
研究概览
简要总结
Patients suffering from pancreas cancer as well as patients with chronic pancreatitis or requiring pancreas surgery often are in a compromised nutritional status. Nutritional support should therefore be started early during the postoperative course to prevent further malnutrition, as it is an important risk factor to develop complications. Recently, several studies have shown that early enteral nutrition (EEN) could shorten length of stay, reduce postoperative infections and mortality, and decrease costs when compared with total parenteral nutrition (TPN) in gastrointestinal cancer surgery. After pancreatoduodenectomy (PD), EEN has been shown to reduce early and late complications, infections, and readmission rates. It is nevertheless currently not clear if EEN improves the short-term outcomes after PD compared to oral nutrition.
The primary objective of the study is to assess the impact of EEN on postoperative morbidity after PD, according to the Comprehensive Complication Index. Secondary objectives are to assess the impact of EEN on major postoperative complications, according to Clavien classification, specific complications, length of stay, readmission rates, quality of life, metabolic stress and nutritional response after PD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient scheduled for elective open pancreatoduodenectomy.
- •Patient ≥18 years old.
- •Patient at nutritional risk, i.e., with Nutrition Risk Screening (NRS) ≥
- •Signed informed consent.
排除标准
- •Patient not able to give informed consent as documented by signature of consent form (e.g., vulnerable patients).
- •Enteral feeding already initiated preoperatively.
- •Language barrier.
- •Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders (i.e., eating disorders and bipolar disorders), or dementia.
结局指标
主要结局
Comprehensive Complication Index
时间窗: Postoperative day 90
Index measuring all complications for a patient
次要结局
- Severe postoperative complications(Postoperative day 90)
- Length of stay(Up to 90 days)
- Readmission(Postoperative day 90)
- Patients' quality of life(Preoperatively and at 30 and 90 days after the operation)
- Resting energy expenditure(On postoperative day 5)
- Body composition(Preoperatively and on the day when patients leave the hospital after the operation)
- Specific complications after pancreatoduodenectomy(Postoperative day 90)
- Metabolic response to enteral nutrition(Preoperatively and twice weekly during the first postoperative week)
- Muscular measure(Preoperatively and on the day when patients leave the hospital after the operation)
研究者
Gaëtan-Romain Joliat
Principal Investigator
University of Lausanne Hospitals