Effects of Preoperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy
NCT ID: NCT01256034
Last Updated: 2012-10-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2009-05-31
2012-03-31
Brief Summary
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Detailed Description
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Object of this study is to investigate the effects preoperative immunonutrition on incidence of postoperative infectious complication, and Th1/Th2 balance after pancreaticoduodenectomy.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group A
preoperative immunonutrition
Oral IMPACT
oral supplementation for 5 days (1L/day) before surgery of a formula enriched with arginine, omega-3 fatty acids, and RNA
Group B
ordinary diet
No interventions assigned to this group
Interventions
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Oral IMPACT
oral supplementation for 5 days (1L/day) before surgery of a formula enriched with arginine, omega-3 fatty acids, and RNA
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Chiba University
OTHER
Responsible Party
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Katsunori Furukawa
MD, PhD
Principal Investigators
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Katsunori Furukawa, MD
Role: STUDY_DIRECTOR
Chiba University
Locations
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Chiba University
Chiba, Chiba, Japan
Countries
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References
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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.
Other Identifiers
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furukawa2009
Identifier Type: -
Identifier Source: org_study_id