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Effects of Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

This study has been completed.
Sponsor:
Information provided by:
Chiba University
ClinicalTrials.gov Identifier:
NCT00668876
First received: April 28, 2008
Last updated: December 2, 2008
Last verified: October 2008
  Purpose

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


Condition Intervention Phase
Pancreaticoduodenectomy
Dietary Supplement: Oral IMPACT
Dietary Supplement: Parenteral nutrition
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effects of Immunonutrition on Surgical Site Infection and Th1/Th2/Th17 Differentiation in Patients Undergoing Pancreaticoduodenectomy

Resource links provided by NLM:


Further study details as provided by Chiba University:

Primary Outcome Measures:
  • surgical site infection after surgery [ Time Frame: 30days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • plasma IL-6, CRP, Th1/Th2 balance, Th17 status [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: May 2006
Study Completion Date: September 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: oral IMPACT; Ajinomoto Pharma Co., Ltd, Tokyo, Japan
Active Comparator: 2
Group B: postoperative immunonutrition
Dietary Supplement: Oral IMPACT
postoperative enteral infusion of the formula with arginine, omega-3 fatty acids, and RNA
Other Name: Oral IMPACT
Active Comparator: 3
Group C: control
Dietary Supplement: Parenteral nutrition
Parenteral nutrition

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668876

Locations
Japan
Chiba University
Chiba, Japan, 260-8670
Sponsors and Collaborators
Chiba University
Investigators
Principal Investigator: Daisuke Suzuki Chiba University
  More Information

No publications provided

Responsible Party: Chiba University
ClinicalTrials.gov Identifier: NCT00668876     History of Changes
Other Study ID Numbers: furukawa2008
Study First Received: April 28, 2008
Last Updated: December 2, 2008
Health Authority: Japan: Institutional Review Board

Keywords provided by Chiba University:
immunonutrition
pancreaticoduodenectomy
Th1
Th2
Th17

ClinicalTrials.gov processed this record on November 25, 2014