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Additional Effects of Perioperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

Primary Purpose

Pancreatic Tumor, Bile Duct Tumor

Status
Unknown status
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 Tumor focused on measuring Immunonutrition

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chiba University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Perioperative

Preoperative

Arm Description

Oral IMPACT (1 L/day) for 5 days before surgery and by enteral feeding after surgery

Oral IMPACT 1000ml/day for 5 days (1 L/day) before surgery

Outcomes

Primary Outcome Measures

plasma resolvin E1, cell-mediated immunity

Secondary Outcome Measures

infectious complication rate

Full Information

First Posted
October 5, 2013
Last Updated
October 24, 2013
Sponsor
Chiba University
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1. Study Identification

Unique Protocol Identification Number
NCT01969110
Brief Title
Additional Effects of Perioperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy
Official Title
Additional Effects of Perioperative Immunonutrition on Th1/Th2 Differentiation in Patients Undergoing Pancreaticoduodenectomy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
September 2015 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Tumor, Bile Duct Tumor
Keywords
Immunonutrition

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Perioperative
Arm Type
Active Comparator
Arm Description
Oral IMPACT (1 L/day) for 5 days before surgery and by enteral feeding after surgery
Arm Title
Preoperative
Arm Type
Active Comparator
Arm Description
Oral IMPACT 1000ml/day for 5 days (1 L/day) before surgery
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral IMPACT
Other Intervention Name(s)
Oral IMPACT; Ajinomoto Pharma Co., Ltd, Tokyo, Japan
Intervention Description
Oral IMPACT enriched with arginine, omega-3 fatty acids, and RNA by enteral feeding after surgery
Primary Outcome Measure Information:
Title
plasma resolvin E1, cell-mediated immunity
Time Frame
30 days
Secondary Outcome Measure Information:
Title
infectious complication rate
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katsunori Furukawa, MD
Phone
+81-43-222-7171
Ext
72235
Email
k-furukawa@umin.ac.jp
First Name & Middle Initial & Last Name or Official Title & Degree
Daisuke Suzuki, MD
Phone
+81-43-222-7171
Ext
72234
Email
d-suzuki@umin.ac.jp
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 Hospital
City
Chiba
ZIP/Postal Code
260-8670
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katsunori Furukawa, MD
Phone
+81-43-222-7171
Ext
72235
Email
k-furukawa@umin.ac.jp

12. IPD Sharing Statement

Learn more about this trial

Additional Effects of Perioperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

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