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Effects of Preoperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy (EPIPD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Katsunori Furukawa, Chiba University
ClinicalTrials.gov Identifier:
NCT01256034
First received: December 7, 2010
Last updated: September 24, 2012
Last verified: September 2012
History of Changes
  Purpose

The purpose of this study is to determine whether preoperative immunonutrition is effective on infectious complication and Th1/Th2 differentiation in patients with pancreaticoduodenectomy.


Condition Intervention Phase
Pancreatic Cancer
Bile Duct Cancer
 Dietary Supplement: Oral IMPACT
 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 Preoperative Immunonutrition on Infectious Complication and Th1/Th2 Differentiation in Patients Undergoing Pancreaticoduodenectomy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chiba University:

Primary Outcome Measures:
  • Postoperative Infectious Complication [ Time Frame: 30 days ] [ Designated as safety issue: No ]

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

Enrollment: 50
Study Start Date: May 2009
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A
preoperative immunonutrition
 Dietary Supplement: Oral IMPACT
oral supplementation for 5 days (1L/day) before surgery of a formula enriched with arginine, omega-3 fatty acids, and RNA
Other Name: Oral IMPACT; Ajinomoto Pharma Co., Ltd, Tokyo, Japan
No Intervention: Group B
ordinary diet

Detailed Description:

The investigators reported that preoperative immunonutrition improve the incidence of postoperative infectious complication in patients after pancreaticoduodenectomy, and modulation of Th1/Th2 differentiation may play important roles in this effect.

Object of this study is to investigate the effects preoperative immunonutrition on incidence of postoperative infectious complication, and Th1/Th2 balance after pancreaticoduodenectomy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients underwent pancreaticoduodenectomy

Exclusion Criteria:

  • age younger than 18 years
  • ongoing infection
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01256034

Locations
Japan
Chiba University
Chiba, Japan, 260-8670
Sponsors and Collaborators
Chiba University
Investigators
Study Director: Katsunori Furukawa, MD Chiba University
  More Information

No publications provided

Responsible Party: Katsunori Furukawa, MD, PhD, Chiba University
ClinicalTrials.gov Identifier: NCT01256034     History of Changes
Other Study ID Numbers: furukawa2009
Study First Received: December 7, 2010
Results First Received: September 24, 2012
Last Updated: September 24, 2012
Health Authority: Japan: Institutional Review Board

Keywords provided by Chiba University:
immunonutrition
pancreaticoduodenectomy
Th1
Th2

Additional relevant MeSH terms:
Pancreatic Neoplasms
Bile Duct Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
 Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Biliary Tract Neoplasms
Bile Duct Diseases
Biliary Tract Diseases

ClinicalTrials.gov processed this record on June 17, 2013