- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01969110
Additional Effects of Perioperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy
October 24, 2013 updated by: Katsunori Furukawa, Chiba University
Additional Effects of Perioperative Immunonutrition on Th1/Th2 Differentiation in Patients Undergoing Pancreaticoduodenectomy
The purpose of this study is to investigate whether perioperative immunonutrition has additional effects on cell-mediated immunity in patients undergoing pancreaticoduodenectomy.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Katsunori Furukawa, MD
- Phone Number: 72235 +81-43-222-7171
- Email: k-furukawa@umin.ac.jp
Study Contact Backup
- Name: Daisuke Suzuki, MD
- Phone Number: 72234 +81-43-222-7171
- Email: d-suzuki@umin.ac.jp
Study Locations
-
-
-
Chiba, Japan, 260-8670
- Recruiting
- Chiba University Hospital
-
Contact:
- Katsunori Furukawa, MD
- Phone Number: 72235 +81-43-222-7171
- Email: k-furukawa@umin.ac.jp
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Perioperative
Oral IMPACT (1 L/day) for 5 days before surgery and by enteral feeding after surgery
|
Oral IMPACT enriched with arginine, omega-3 fatty acids, and RNA by enteral feeding after surgery
Other Names:
|
ACTIVE_COMPARATOR: Preoperative
Oral IMPACT 1000ml/day for 5 days (1 L/day) before surgery
|
Oral IMPACT enriched with arginine, omega-3 fatty acids, and RNA by enteral feeding after surgery
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
plasma resolvin E1, cell-mediated immunity
Time Frame: 30 days
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
infectious complication rate
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (ANTICIPATED)
September 1, 2015
Study Completion (ANTICIPATED)
September 1, 2015
Study Registration Dates
First Submitted
October 5, 2013
First Submitted That Met QC Criteria
October 24, 2013
First Posted (ESTIMATE)
October 25, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
October 25, 2013
Last Update Submitted That Met QC Criteria
October 24, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AEPIPD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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