Parenteral Nutrition in Patients With Biliopancreatic Mass Lesions (NUPAN)

University Medicine Greifswald

Status: Completed

Conditions: Weight Loss; Biliary Tract Cancer; Pancreatic Cancer

Treatments: Dietary Supplement: Olimel Peri 2.5% ®; Dietary Supplement: Isotonic fluid (E153)

Study type: Interventional

Funder types: Other

Identifiers

NCT02670265

BB61/12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)
• Dementia
• Pregnancy
• Hospital stay less than 3 days

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups, including a placebo group

Parenteral nutrition

Active Comparator group

Description:

Active Comparator: Olimel peri 2.5% ® 1l/d (700 kcal/d) (Baxter GmbH, Unterschleißheim, Germany)

Treatment:

Dietary Supplement: Olimel Peri 2.5% ®

Isotonic fluid

Placebo Comparator group

Description:

Isotonic fluid 1l/d (E153, Berlin-Chemie AG, Berlin, Germany)

Treatment:

Dietary Supplement: Isotonic fluid (E153)