Parenteral Nutrition in Patients With Biliopancreatic Mass Lesions

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.

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

Conditions
-----------------
Weight Loss, Pancreatic Cancer, Biliary Tract Cancer

Intervention / Treatment
-----------------
* Dietary Supplement: Olimel Peri 2.5% ®
* Dietary Supplement: Isotonic fluid (E153)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Parenteral nutrition<br>Active Comparator: Olimel peri 2.5% ® 1l/d (700 kcal/d) (Baxter GmbH, Unterschleißheim, Germany) | Dietary Supplement: Olimel Peri 2.5% ®<br>* 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.<br>|
| Placebo Comparator: Isotonic fluid<br>Isotonic fluid 1l/d (E153, Berlin-Chemie AG, Berlin, Germany) | Dietary Supplement: Isotonic fluid (E153)<br>* Controls received 1l of isotonic fluid daily by intravenous route.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | Influence of Olimel Peri 2.%% ® on body weight | ≥ 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional status | Bioelectrical analysis (BIA) was performed. BCM/ECM index, phase angle, body fat were measured. | ≥ 3 days | 
| Quality of life | Quality of life was determined using the European EORTC QLQ-C30 form. | ≥ 3 days | 
| Length of hospital stay | Length of hospital stay was calculated in days. | ≥ 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
malnutrition, parenteral nutrition, weight loss, pancreatic cancer, biliary tract cancer, quality of life