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Effects of Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

NCT ID: NCT00668876

Last Updated: 2008-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2008-09-30

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.

Conditions

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Pancreaticoduodenectomy

Keywords

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immunonutrition pancreaticoduodenectomy Th1 Th2 Th17

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Group A: perioperative immunonutrition

Group Type ACTIVE_COMPARATOR

Oral IMPACT

Intervention Type DIETARY_SUPPLEMENT

oral supplementation for 5 days(1 L/d )before surgery of a formula enriched with arginine, omega-3 fatty acids, and RNA

2

Group B: postoperative immunonutrition

Group Type ACTIVE_COMPARATOR

Oral IMPACT

Intervention Type DIETARY_SUPPLEMENT

postoperative enteral infusion of the formula with arginine, omega-3 fatty acids, and RNA

3

Group C: control

Group Type ACTIVE_COMPARATOR

Parenteral nutrition

Intervention Type DIETARY_SUPPLEMENT

Parenteral nutrition

Interventions

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Oral IMPACT

oral supplementation for 5 days(1 L/d )before surgery of a formula enriched with arginine, omega-3 fatty acids, and RNA

Intervention Type DIETARY_SUPPLEMENT

Oral IMPACT

postoperative enteral infusion of the formula with arginine, omega-3 fatty acids, and RNA

Intervention Type DIETARY_SUPPLEMENT

Parenteral nutrition

Parenteral nutrition

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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oral IMPACT; Ajinomoto Pharma Co., Ltd, Tokyo, Japan

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chiba University

OTHER

Sponsor Role lead

Responsible Party

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Chiba University

Principal Investigators

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Daisuke Suzuki

Role: PRINCIPAL_INVESTIGATOR

Chiba University

Locations

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Chiba University

Chiba, Chiba, Japan

Site Status

Countries

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Japan

Other Identifiers

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furukawa2008

Identifier Type: -

Identifier Source: org_study_id