Clinical trial NCT02670265: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Pancreatic Cancer
Biliary Tract Cancer
Keywords: malnutrition
parenteral nutrition
weight loss
pancreatic cancer
biliary tract cancer
quality of life
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2016-02-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight loss
timeFrame: ≥ 3 days
Secondary outcomes:
measure: Nutritional status
timeFrame: ≥ 3 days
measure: Quality of life
timeFrame: ≥ 3 days
measure: Length of hospital stay
timeFrame: ≥ 3 days
Other outcomes:
Locations:
Study officials:
affiliation: Department of Medicine A, University Medicine Greifswald
name: Markus M Lerch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kruger J, Meffert PJ, Vogt LJ, Gartner S, Steveling A, Kraft M, Mayerle J, Lerch MM, Aghdassi AA. Early Parenteral Nutrition in Patients with Biliopancreatic Mass Lesions, a Prospective, Randomized Intervention Trial. PLoS One. 2016 Nov 18;11(11):e0166513. doi: 10.1371/journal.pone.0166513. eCollection 2016.