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Clinical Trials/NCT01256034
NCT01256034CompletedPhase 4

Effects of Preoperative Immunonutrition on Infectious Complication and Th1/Th2 Differentiation in Patients Undergoing Pancreaticoduodenectomy

Chiba University2 sites in 1 country50 target enrollmentStarted: May 2009Last updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
50
Locations
2
Primary Endpoint
Postoperative Infectious Complication
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Postoperative Infectious Complication

Time Frame: 30 days

Secondary Outcomes

  • Plasma IL-6, CRP, Th1/Th2 Balance(14 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Katsunori Furukawa

MD, PhD

Chiba University

Study Sites (2)

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