Effects of Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00668876
Recruitment Status : Completed
First Posted : April 29, 2008
Last Update Posted : December 3, 2008
Information provided by:
Chiba University

Brief Summary:
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 or disease Intervention/treatment Phase
Pancreaticoduodenectomy Dietary Supplement: Oral IMPACT Dietary Supplement: Parenteral nutrition Phase 4

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  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of Immunonutrition on Surgical Site Infection and Th1/Th2/Th17 Differentiation in Patients Undergoing Pancreaticoduodenectomy
Study Start Date : May 2006
Actual Primary Completion Date : January 2008
Actual Study Completion Date : September 2008

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 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

Active Comparator: 3
Group C: control
Dietary Supplement: Parenteral nutrition
Parenteral nutrition

Primary Outcome Measures :
  1. surgical site infection after surgery [ Time Frame: 30days ]

Secondary Outcome Measures :
  1. plasma IL-6, CRP, Th1/Th2 balance, Th17 status [ Time Frame: 14 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00668876

Chiba University
Chiba, Japan, 260-8670
Sponsors and Collaborators
Chiba University
Principal Investigator: Daisuke Suzuki Chiba University

Responsible Party: Chiba University Identifier: NCT00668876     History of Changes
Other Study ID Numbers: furukawa2008
First Posted: April 29, 2008    Key Record Dates
Last Update Posted: December 3, 2008
Last Verified: October 2008

Keywords provided by Chiba University: