Effects of Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

December 2, 2008 updated by: Chiba University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chiba, Japan, 260-8670
        • Chiba University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Group A: perioperative immunonutrition
Dietary supplement: Oral IMPACT
oral supplementation for 5 days(1 L/d )before surgery of a formula enriched with arginine, omega-3 fatty acids, and RNA
Other Names:
  • oral IMPACT; Ajinomoto Pharma Co., Ltd, Tokyo, Japan
Dietary supplement: Oral IMPACT
postoperative enteral infusion of the formula with arginine, omega-3 fatty acids, and RNA
Active Comparator: 2
Group B: postoperative immunonutrition
Dietary supplement: Oral IMPACT
oral supplementation for 5 days(1 L/d )before surgery of a formula enriched with arginine, omega-3 fatty acids, and RNA
Other Names:
  • oral IMPACT; Ajinomoto Pharma Co., Ltd, Tokyo, Japan
Dietary supplement: Oral IMPACT
postoperative enteral infusion of the formula with arginine, omega-3 fatty acids, and RNA
Active Comparator: 3
Group C: control
Dietary supplement: Parenteral nutrition
Parenteral nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
surgical site infection after surgery
Time Frame: 30days
30days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiba University

Investigators

  • Principal Investigator: Daisuke Suzuki, Chiba University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

April 28, 2008

First Submitted That Met QC Criteria

April 28, 2008

First Posted (Estimate)

April 29, 2008

Study Record Updates

Last Update Posted (Estimate)

December 3, 2008

Last Update Submitted That Met QC Criteria

December 2, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • furukawa2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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