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

Study Overview
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Brief Summary
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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.

Official Title
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Randomized, Controlled Trial Investigating the Effect of Preoperative Oral Immunonutrition on Complications and Length of Hospital Stay After Elective Surgery for Pancreatic Cancer

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Dietary Supplement: Oral Impact, Nestlé Health Science


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Impact, Nestlé Health Science<br>Oral Impact-arm receives the intervention the last 7 days prior to surgery | Dietary Supplement: Oral Impact, Nestlé Health Science<br>* 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.<br>|
| No Intervention: Control<br>The control-arm receives no intervention but is treated according to the standard procedures | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall postoperative complications after major gastrointestinal (GI) elective surgery. |  | Within the first 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay after major gastrointestinal (GI) elective surgery |  | Within the first 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative, Complications, Elective, Surgery, GI surgery, Immunonutrition, Immune-enhancing, Immune-modulating, Nutrition, Pancreatic cancer, Postoperative complications and length of hospital stay after major gastrointestinal (GI) elective surgery.