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Effects of Preoperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy (EPIPD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01256034
First Posted: December 8, 2010
Last Update Posted: October 23, 2012
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.
Information provided by (Responsible Party):
Katsunori Furukawa, Chiba University
  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
Intervention Model: Parallel Assignment
Masking: None (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 Katsunori Furukawa, Chiba University:

Primary Outcome Measures:
  • Postoperative Infectious Complication [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • Plasma IL-6, CRP, Th1/Th2 Balance [ Time Frame: 14 days ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT01256034


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Katsunori Furukawa, MD, PhD, Chiba University
ClinicalTrials.gov Identifier: NCT01256034     History of Changes
Other Study ID Numbers: furukawa2009
First Submitted: December 7, 2010
First Posted: December 8, 2010
Results First Submitted: September 24, 2012
Results First Posted: October 23, 2012
Last Update Posted: October 23, 2012
Last Verified: September 2012

Keywords provided by Katsunori Furukawa, Chiba University:
immunonutrition
pancreaticoduodenectomy
Th1
Th2

Additional relevant MeSH terms:
Pancreatic Neoplasms
Bile Duct Neoplasms
Cholangiocarcinoma
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
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type