Parenteral Nutrition in Patients With Biliopancreatic Mass Lesions
NUPAN
Early Parenteral Nutrition in Patients With Biliopancreatic Mass Lesions (NUPAN), a Prospective Randomized Interventional Trial
1 other identifier
interventional
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2012
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 28, 2016
CompletedFirst Posted
Study publicly available on registry
February 1, 2016
CompletedFebruary 1, 2016
January 1, 2016
1.7 years
January 28, 2016
January 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight loss
Influence of Olimel Peri 2.%% ® on body weight
≥ 3 days
Secondary Outcomes (3)
Nutritional status
≥ 3 days
Quality of life
≥ 3 days
Length of hospital stay
≥ 3 days
Study Arms (2)
Parenteral nutrition
ACTIVE COMPARATORActive Comparator: Olimel peri 2.5% ® 1l/d (700 kcal/d) (Baxter GmbH, Unterschleißheim, Germany)
Isotonic fluid
PLACEBO COMPARATORIsotonic fluid 1l/d (E153, Berlin-Chemie AG, Berlin, Germany)
Interventions
During hospital stay patients received 1 l Olimel peri 2.5 %® containing 700 kcal (25.3 g protein, 30.0 g fat and 75.0 g glucose) daily by intravenous route.
Controls received 1l of isotonic fluid daily by intravenous route.
Eligibility Criteria
You may qualify if:
- Hospitalization for suspected biliopancreatic mass lesion
- Consent to participate to the study
You may not qualify if:
- Liver cirrhosis (Child-Pugh B and C)
- Heart or renal failure (grade III or more)
- Dementia
- Pregnancy
- Hospital stay less than 3 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 27861546DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Markus M Lerch, MD
Department of Medicine A, University Medicine Greifswald
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2016
First Posted
February 1, 2016
Study Start
June 1, 2012
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
February 1, 2016
Record last verified: 2016-01
Data Sharing
- IPD Sharing
- Will not share