Additional Effects of Perioperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

Study Overview
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Brief Summary
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The purpose of this study is to investigate whether perioperative immunonutrition has additional effects on cell-mediated immunity in patients undergoing pancreaticoduodenectomy.

Detailed Description
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The investigators reported that perioperative immunonutrition had no additional effects compared with preoperative immunonutrition in patients underwent colorectal surgery (Braga M, Gianotti L, Vignali A, Carlo VD. Preoperative oral arginine and n-3 fatty acid supplementation improves the immunometabolic host response and outcome after colorectal resection for cancer. Surgery. 2002; 132:805-14, PMID: 12464864). Object of this study is to investigate the additional effects of perioperative immunonutrition on cell-mediated immunity and incidence of infectious complication after pancreaticoduodenectomy.

Official Title
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Additional Effects of Perioperative Immunonutrition on Th1/Th2 Differentiation in Patients Undergoing Pancreaticoduodenectomy

Conditions
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Pancreatic Tumor, Bile Duct Tumor

Intervention / Treatment
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* Dietary Supplement: Oral IMPACT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing pancreaticoduodenectomy Exclusion Criteria: age younger than 18 years old ongoing infection gastrointestinal obstruction respiratory dysfunction cardiac dysfunction hepatic dysfunction renal failure history of recent immunosuppressive or immunological disease preoperative evidence of widespread metastatic disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Perioperative<br>Oral IMPACT (1 L/day) for 5 days before surgery and by enteral feeding after surgery | Dietary Supplement: Oral IMPACT<br>* Oral IMPACT enriched with arginine, omega-3 fatty acids, and RNA by enteral feeding after surgery<br>* Other names: Oral IMPACT; Ajinomoto Pharma Co., Ltd, Tokyo, Japan;|
| Active Comparator: Preoperative<br>Oral IMPACT 1000ml/day for 5 days (1 L/day) before surgery | Dietary Supplement: Oral IMPACT<br>* Oral IMPACT enriched with arginine, omega-3 fatty acids, and RNA by enteral feeding after surgery<br>* Other names: Oral IMPACT; Ajinomoto Pharma Co., Ltd, Tokyo, Japan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma resolvin E1, cell-mediated immunity |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| infectious complication rate |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunonutrition