Effects of Preoperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy (EPIPD)

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

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.


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

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01256034

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

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:

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms by Site
Pancreatic Diseases

ClinicalTrials.gov processed this record on May 24, 2016