Spots Global Cancer Trial Database for Parenteral Nutrition in Patients With Biliopancreatic Mass Lesions

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Trial Identification

Brief Title: Parenteral Nutrition in Patients With Biliopancreatic Mass Lesions

Official Title: Early Parenteral Nutrition in Patients With Biliopancreatic Mass Lesions (NUPAN), a Prospective Randomized Interventional Trial

Study ID: NCT02670265

Conditions

Weight Loss

Pancreatic Cancer

Biliary Tract Cancer

Interventions

Olimel Peri 2.5% ®

Isotonic fluid (E153)

Study Description

Brief Summary: 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.

Detailed Description: 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.