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NCT Number: NCT02670265

Parenteral Nutrition in Patients With Biliopancreatic Mass Lesions

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.

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Key information

Conditions

Weight Loss Biliary Tract Cancer Biliary Tract Diseases Biliary Tract Neoplasms Body Weight Body Weight Changes Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Hyperphagia Malnutrition Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olimel Peri 2.5% ®

Dietary Supplement

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.

Isotonic fluid (E153)

Dietary Supplement

Controls received 1l of isotonic fluid daily by intravenous route.

Primary outcomes

  1. Weight loss

    Time frame: ≥ 3 days

    Influence of Olimel Peri 2.%% ® on body weight

Secondary outcomes

  1. Nutritional status

    Time frame: ≥ 3 days

    Bioelectrical analysis (BIA) was performed. BCM/ECM index, phase angle, body fat were measured.

  2. Quality of life

    Time frame: ≥ 3 days

    Quality of life was determined using the European EORTC QLQ-C30 form.

  3. Length of hospital stay

    Time frame: ≥ 3 days

    Length of hospital stay was calculated in days.

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

Registry information

Official study title

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

Acronym: NUPAN

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 1, 2016
Registry last updated
Feb 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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