Early Parenteral Nutrition in Patients With Biliopancreatic Mass Lesions (NUPAN), a Prospective Randomized Interventional Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 主要终点
- Weight loss
研究概览
简要总结
Patients with biliopancreatic tumors are at risk for malnutrition and have to undergo many procedures for diagnostic workup that require fasting periods. In a prospective randomized monocentric study we evaluate the effect of additional parenteral nutrition on weight loss, nutritional status, quality of life and length of hospital stay.
详细描述
Patients with pancreatic and biliary tract cancer suffer from weight loss, malnutrition and cachexia. These factors are associated with poor prognosis, reduction in quality of life and a higher risk of complications during treatment. Moreover, patients undergo fasting periods during their diagnostic work-up at hospital that worsens malnutrition.
This is a prospective randomized monocentric study to investigate, whether parenteral nutritional supplementation may have an impact on weight loss, nutritional status, quality of life and length of hospital stay in patients with tumors of the pancreas or biliary tract. Patients either receive 1 l Olimel peri 2.5 %® (Baxter Germany GmbH Medication Delivery, Unterschleißheim, Germany containing 700 kcal, 25.3 g protein, 30.0 g fat and 75.0 g glucose) on fasting days or 1 l of isotonic fluid (E153, Berlin-Chemie AG, Berlin, Germany) in the control group. A hospital stay of at least three days is required. Patients are assessed for anthropometric measurements, bioelectrical impedance analysis, quality of life and length of hospital stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Hospitalization for suspected biliopancreatic mass lesion
- •Consent to participate to the study
排除标准
- •Liver cirrhosis (Child-Pugh B and C)
- •Heart or renal failure (grade III or more)
- •Pregnancy
- •Hospital stay less than 3 days
研究组 & 干预措施
Parenteral nutrition
Active Comparator: Olimel peri 2.5% ® 1l/d (700 kcal/d) (Baxter GmbH, Unterschleißheim, Germany)
干预措施: Olimel Peri 2.5% ® (Dietary Supplement)
Isotonic fluid
Isotonic fluid 1l/d (E153, Berlin-Chemie AG, Berlin, Germany)
干预措施: Isotonic fluid (E153) (Dietary Supplement)
结局指标
主要结局
Weight loss
时间窗: ≥ 3 days
Influence of Olimel Peri 2.%% ® on body weight
次要结局
- Quality of life(≥ 3 days)
- Nutritional status(≥ 3 days)
- Length of hospital stay(≥ 3 days)