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 |
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Recruitment Status :
Completed
First Posted : February 11, 2013
Last Update Posted : December 23, 2013
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Sponsor:
University of Copenhagen
Collaborator:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Arne Astrup, University of Copenhagen
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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 |
| 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
MedlinePlus related topics:
Pancreatic Cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: Oral Impact, Nestlé Health Science
Oral Impact-arm receives the intervention the last 7 days prior to surgery
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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. |
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No Intervention: Control
The control-arm receives no intervention but is treated according to the standard procedures
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Primary Outcome Measures :
- Overall postoperative complications after major gastrointestinal (GI) elective surgery. [ Time Frame: Within the first 30 days after surgery ]
Secondary Outcome Measures :
- Length of hospital stay after major gastrointestinal (GI) elective surgery [ Time Frame: Within the first 30 days after surgery ]
Other Outcome Measures:
- Weight stability, functional capability and patients´ satisfaction with the overall study course. [ Time Frame: from recruitment and within 30 days after surgery ]
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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
| Denmark | |
| Surgical Gastroenterology Clinic C, Ward 2122, Rigshospitalet | |
| Copenhagen, Denmark, 2100 | |
Sponsors and Collaborators
University of Copenhagen
Rigshospitalet, Denmark
Investigators
| Principal Investigator: | Jens R Andersen, Chief Phys., Ass. Prof. | University of Copenhagen |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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:
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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 |