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

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ClinicalTrials.gov Identifier: NCT01789073
Recruitment Status : Completed
First Posted : February 11, 2013
Last Update Posted : December 23, 2013
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Arne Astrup, University of Copenhagen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Dietary Supplement: Oral Impact, Nestlé Health Science Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Randomized, Controlled Trial Investigating the Effect of Preoperative Oral Immunonutrition on Complications and Length of Hospital Stay After Elective Surgery for Pancreatic Cancer
Study Start Date : February 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/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 according to a protein requirement of 1.5 g/kg bodyweight/day (subtracted their habitual protein intake). Each patient receives this dosage orally the last 7 days prior to surgery.

No Intervention: Control
The control-arm receives no intervention but is treated according to the standard procedures



Primary Outcome Measures :
  1. Overall postoperative complications after major gastrointestinal (GI) elective surgery. [ Time Frame: Within the first 30 days after surgery ]

Secondary Outcome Measures :
  1. Length of hospital stay after major gastrointestinal (GI) elective surgery [ Time Frame: Within the first 30 days after surgery ]

Other Outcome Measures:
  1. Weight stability, functional capability and patients´ satisfaction with the overall study course. [ Time Frame: from recruitment and within 30 days after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01789073


Locations
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Denmark
Surgical Gastroenterology Clinic C, Ward 2122, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
University of Copenhagen
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Jens R Andersen, Chief Phys., Ass. Prof. University of Copenhagen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Arne Astrup, Chief of Institute of Human Nutrition, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01789073    
Other Study ID Numbers: H-1-2012-146
First Posted: February 11, 2013    Key Record Dates
Last Update Posted: December 23, 2013
Last Verified: December 2013
Keywords provided by Arne Astrup, University of Copenhagen:
Pancreatic cancer
Postoperative
Complications
Elective
Surgery
GI surgery
Immunonutrition
Immune-enhancing
Immune-modulating
Nutrition
Postoperative complications and length of hospital stay after major gastrointestinal (GI) elective surgery.
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases