Effects of Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

Study Overview
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Brief Summary
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The purpose of this study is to determine whether immunonutrition is effective on surgical site infection and Th1/Th2/Th17 differentiation in patients undergoing pancreaticoduodenectomy

Detailed Description
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Perioperative immunonutrition is reported to improve the incidence of postoperative infectious complication in patients with gastrointestinal surgery. It has also been recognized that Th1/Th2 balance shifts toward Th2 by surgical stress. On the other hand, the change of Th17 status after surgery has not been established. Furthermore, The change of Th1/Th2 balance and Th17 status with immunonutrition on pancreaticoduodenectomy have not been reported yet. Objective of this study is to investigate the effects of perioperative immunonutrition on incidence of postoperative infectious complication, Th1/Th2 balance and Th17 status after pancreaticoduodenectomy.

Official Title
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Effects of Immunonutrition on Surgical Site Infection and Th1/Th2/Th17 Differentiation in Patients Undergoing Pancreaticoduodenectomy

Conditions
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Pancreaticoduodenectomy

Intervention / Treatment
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* Dietary Supplement: Oral IMPACT
* Dietary Supplement: Oral IMPACT
* Dietary Supplement: Parenteral nutrition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients underwent pancreaticoduodenectomy Exclusion Criteria: age younger than 18 years or older than 75 years preoperative chemotherapy or radiation ongoing infection diabetes mellitus gastrointestinal obstruction respiratory dysfunction cardiac dysfunction hepatic dysfunction renal failure history of recent immunosuppressive or immunological diseases preoperative evidence of widespread metastatic disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: 1<br>Group A: perioperative immunonutrition | Dietary Supplement: Oral IMPACT<br>* oral supplementation for 5 days(1 L/d )before surgery of a formula enriched with arginine, omega-3 fatty acids, and RNA<br>* Other names: oral IMPACT; Ajinomoto Pharma Co., Ltd, Tokyo, Japan;|
| Active Comparator: 2<br>Group B: postoperative immunonutrition | Dietary Supplement: Oral IMPACT<br>* postoperative enteral infusion of the formula with arginine, omega-3 fatty acids, and RNA<br>|
| Active Comparator: 3<br>Group C: control | Dietary Supplement: Parenteral nutrition<br>* Parenteral nutrition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical site infection after surgery |  | 30days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma IL-6, CRP, Th1/Th2 balance, Th17 status |  | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immunonutrition, pancreaticoduodenectomy, Th1, Th2, Th17