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Additional Effects of Perioperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

Sponsor
Chiba University (Other)
Overall Status
Unknown status
CT.gov ID
NCT01969110
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
32
Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Oral IMPACT
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Additional Effects of Perioperative Immunonutrition on Th1/Th2 Differentiation in Patients Undergoing Pancreaticoduodenectomy
Study Start Date :
Jan 1, 2013
Anticipated Primary Completion Date :
Sep 1, 2015
Anticipated Study Completion Date :
Sep 1, 2015

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. plasma resolvin E1, cell-mediated immunity [30 days]

    Secondary Outcome Measures

    1. infectious complication rate [30 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chiba University Hospital Chiba Japan 260-8670

    Sponsors and Collaborators

    • Chiba University

    Investigators

    • Study Director: Katsunori Furukawa, MD, Chiba University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Katsunori Furukawa, MD, PhD, Chiba University
    ClinicalTrials.gov Identifier:
    NCT01969110
    Other Study ID Numbers:
    • AEPIPD
    First Posted:
    Oct 25, 2013
    Last Update Posted:
    Oct 25, 2013
    Last Verified:
    Oct 1, 2013
    Keywords provided by Katsunori Furukawa, MD, PhD, Chiba University
    Immunonutrition
    Additional relevant MeSH terms:
    Pancreatic Neoplasms

    Study Results

    No Results Posted as of Oct 25, 2013