Effects of Preoperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy
EPIPD
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 pancreatic-cancer
Started May 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 7, 2010
CompletedFirst Posted
Study publicly available on registry
December 8, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedResults Posted
Study results publicly available
October 23, 2012
CompletedOctober 23, 2012
September 1, 2012
2.8 years
December 7, 2010
September 24, 2012
September 24, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative Infectious Complication
30 days
Secondary Outcomes (1)
Plasma IL-6, CRP, Th1/Th2 Balance
14 days
Study Arms (2)
Group A
ACTIVE COMPARATORpreoperative immunonutrition
Group B
NO INTERVENTIONordinary diet
Interventions
oral supplementation for 5 days (1L/day) before surgery of a formula enriched with arginine, omega-3 fatty acids, and RNA
Eligibility Criteria
You may qualify if:
- patients underwent pancreaticoduodenectomy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chiba Universitylead
Study Sites (1)
Chiba University
Chiba, Chiba, 260-8670, Japan
Related Publications (1)
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.
PMID: 24589090DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Katsunori Furukawa
- Organization
- Chiba University Graduate School of Medicine
Study Officials
- STUDY DIRECTOR
Katsunori Furukawa, MD
Chiba University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
December 7, 2010
First Posted
December 8, 2010
Study Start
May 1, 2009
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
October 23, 2012
Results First Posted
October 23, 2012
Record last verified: 2012-09