Additional Effects of Perioperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

October 24, 2013 updated by: Katsunori Furukawa, Chiba University

Additional Effects of Perioperative Immunonutrition on Th1/Th2 Differentiation in Patients Undergoing Pancreaticoduodenectomy

The purpose of this study is to investigate whether perioperative immunonutrition has additional effects on cell-mediated immunity in patients undergoing pancreaticoduodenectomy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The investigators reported that perioperative immunonutrition had no additional effects compared with preoperative immunonutrition in patients underwent colorectal surgery (Braga M, Gianotti L, Vignali A, Carlo VD. Preoperative oral arginine and n-3 fatty acid supplementation improves the immunometabolic host response and outcome after colorectal resection for cancer. Surgery. 2002; 132:805-14, PMID: 12464864). Object of this study is to investigate the additional effects of perioperative immunonutrition on cell-mediated immunity and incidence of infectious complication after pancreaticoduodenectomy.

Study Type

Interventional

Enrollment (Anticipated)

60

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
        • Recruiting
        • Chiba University Hospital
        • Contact:

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 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients undergoing pancreaticoduodenectomy

Exclusion Criteria:

  • age younger than 18 years old
  • ongoing infection
  • gastrointestinal obstruction
  • respiratory dysfunction
  • cardiac dysfunction
  • hepatic dysfunction
  • renal failure
  • history of recent immunosuppressive or immunological disease
  • 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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Perioperative
Oral IMPACT (1 L/day) for 5 days before surgery and by enteral feeding after surgery
Dietary supplement: Oral IMPACT
Oral IMPACT enriched with arginine, omega-3 fatty acids, and RNA by enteral feeding after surgery
Other Names:
  • Oral IMPACT; Ajinomoto Pharma Co., Ltd, Tokyo, Japan
ACTIVE_COMPARATOR: Preoperative
Oral IMPACT 1000ml/day for 5 days (1 L/day) before surgery
Dietary supplement: Oral IMPACT
Oral IMPACT enriched with arginine, omega-3 fatty acids, and RNA by enteral feeding after surgery
Other Names:
  • Oral IMPACT; Ajinomoto Pharma Co., Ltd, Tokyo, Japan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
plasma resolvin E1, cell-mediated immunity
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
infectious complication rate
Time Frame: 30 days
30 days

Collaborators and Investigators

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

Sponsor

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

January 1, 2013

Primary Completion (ANTICIPATED)

September 1, 2015

Study Completion (ANTICIPATED)

September 1, 2015

Study Registration Dates

First Submitted

October 5, 2013

First Submitted That Met QC Criteria

October 24, 2013

First Posted (ESTIMATE)

October 25, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 25, 2013

Last Update Submitted That Met QC Criteria

October 24, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AEPIPD

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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