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Preoperative Oral Immunonutrition for Patients With Pancreatic Cancer Undergoing Elective Surgery - Effect on Complications and Length of Hospital Stay


2013-02


2013-12


2013-12


35

Study Overview

Preoperative Oral Immunonutrition for Patients With Pancreatic Cancer Undergoing Elective Surgery - Effect on Complications and Length of Hospital Stay

The purpose of this study is to investigate the effect of preoperative immunonutrition on complications and length of hospital stay in patients with pancreatic cancer undergoing elective surgery.

N/A

  • Pancreatic Cancer
  • DIETARY_SUPPLEMENT: Oral Impact, Nestlé Health Science
  • H-1-2012-146

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2013-02-07  

N/A  

2013-12-20  

2013-02-08  

N/A  

2013-12-23  

2013-02-11  

N/A  

2013-12  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Supportive Care


Allocation:
Randomized


Interventional Model:
Parallel


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Oral Impact, Nestlé Health Science

Oral Impact-arm receives the intervention the last 7 days prior to surgery

DIETARY_SUPPLEMENT: Oral Impact, Nestlé Health Science

  • Oral Impact from Nestlé Health Science. An enteral nutritional supplement high in protein and with added immune-enhancing nutrients: arginine, fish oil and nucleotides. The intervention arm receives Oral Impact in an individually estimated dosage accordin
NO_INTERVENTION: Control

The control-arm receives no intervention but is treated according to the standard procedures

Primary Outcome MeasuresMeasure DescriptionTime Frame
Overall postoperative complications after major gastrointestinal (GI) elective surgery.Within the first 30 days after surgery
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Length of hospital stay after major gastrointestinal (GI) elective surgeryWithin the first 30 days after surgery

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:

  • Men and women referred to treatment at Surgical Gastroenterology Clinic C, Ward 2122 for pancreatic cancer
  • Age > 18 years.

  • Exclusion Criteria:

  • Age < 18 years
  • Pregnant and lactating women
  • Persons who cannot understand and/or speak Danish
  • Renal dysfunction
  • Milk allergy
  • Participants are excluded if elective surgery is not indicated after all

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • Rigshospitalet, Denmark

  • PRINCIPAL_INVESTIGATOR: Jens R Andersen, Chief Phys., Ass. Prof., University of Copenhagen

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Gade J, Levring T, Hillingso J, Hansen CP, Andersen JR. The Effect of Preoperative Oral Immunonutrition on Complications and Length of Hospital Stay After Elective Surgery for Pancreatic Cancer--A Randomized Controlled Trial. Nutr Cancer. 2016;68(2):225-33. doi: 10.1080/01635581.2016.1142586. Epub 2016 Mar 4.