Early Parenteral Nutrition in Patients With Biliopancreatic Mass Lesions (NUPAN), a Prospective Randomized Interventional Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Primary Endpoint
- Weight loss
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Hospitalization for suspected biliopancreatic mass lesion
- •Consent to participate to the study
Exclusion Criteria
- •Liver cirrhosis (Child-Pugh B and C)
- •Heart or renal failure (grade III or more)
- •Pregnancy
- •Hospital stay less than 3 days
Arms & Interventions
Parenteral nutrition
Active Comparator: Olimel peri 2.5% ® 1l/d (700 kcal/d) (Baxter GmbH, Unterschleißheim, Germany)
Intervention: Olimel Peri 2.5% ® (Dietary Supplement)
Isotonic fluid
Isotonic fluid 1l/d (E153, Berlin-Chemie AG, Berlin, Germany)
Intervention: Isotonic fluid (E153) (Dietary Supplement)
Outcomes
Primary Outcomes
Weight loss
Time Frame: ≥ 3 days
Influence of Olimel Peri 2.%% ® on body weight
Secondary Outcomes
- Quality of life(≥ 3 days)
- Nutritional status(≥ 3 days)
- Length of hospital stay(≥ 3 days)