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Effects of Preoperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy (EPIPD)

Primary Purpose

Pancreatic Cancer, Bile Duct Cancer

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Oral IMPACT
Sponsored by
Chiba University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pancreatic Cancer focused on measuring immunonutrition, pancreaticoduodenectomy, Th1, Th2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chiba University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Group A

Group B

Arm Description

preoperative immunonutrition

ordinary diet

Outcomes

Primary Outcome Measures

Postoperative Infectious Complication

Secondary Outcome Measures

Plasma IL-6, CRP, Th1/Th2 Balance

Full Information

First Posted
December 7, 2010
Last Updated
September 24, 2012
Sponsor
Chiba University
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1. Study Identification

Unique Protocol Identification Number
NCT01256034
Brief Title
Effects of Preoperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy
Acronym
EPIPD
Official Title
Effects of Preoperative Immunonutrition on Infectious Complication and Th1/Th2 Differentiation in Patients Undergoing Pancreaticoduodenectomy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chiba University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Bile Duct Cancer
Keywords
immunonutrition, pancreaticoduodenectomy, Th1, Th2

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
preoperative immunonutrition
Arm Title
Group B
Arm Type
No Intervention
Arm Description
ordinary diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral IMPACT
Other Intervention Name(s)
Oral IMPACT; Ajinomoto Pharma Co., Ltd, Tokyo, Japan
Intervention Description
oral supplementation for 5 days (1L/day) before surgery of a formula enriched with arginine, omega-3 fatty acids, and RNA
Primary Outcome Measure Information:
Title
Postoperative Infectious Complication
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Plasma IL-6, CRP, Th1/Th2 Balance
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katsunori Furukawa, MD
Organizational Affiliation
Chiba University
Official's Role
Study Director
Facility Information:
Facility Name
Chiba University
City
Chiba
ZIP/Postal Code
260-8670
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
24589090
Citation
Aida T, Furukawa K, Suzuki D, Shimizu H, Yoshidome H, Ohtsuka M, Kato A, Yoshitomi H, Miyazaki M. Preoperative immunonutrition decreases postoperative complications by modulating prostaglandin E2 production and T-cell differentiation in patients undergoing pancreatoduodenectomy. Surgery. 2014 Jan;155(1):124-33. doi: 10.1016/j.surg.2013.05.040. Epub 2013 Oct 25.
Results Reference
derived

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Effects of Preoperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

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