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NCT01256034 Clinical Trial

Effects of Preoperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

Pancreatic Cancer Clinical Trial

— EPIPD  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01256034
Other study ID # furukawa2009
Secondary ID
Status Completed
Phase Phase 4
First received December 7, 2010
Last updated September 24, 2012
Start date May 2009
Est. completion date March 2012

Study information
Verified date September 2012
Source Chiba University
Contact n/a
Is FDA regulated No
Health authority Japan: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Oral IMPACT
oral supplementation for 5 days (1L/day) before surgery of a formula enriched with arginine, omega-3 fatty acids, and RNA

Locations
Country Name City State
Japan Chiba University Chiba

Sponsors (1)
Lead Sponsor Collaborator
Chiba University

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative Infectious Complication 30 days No
Secondary Plasma IL-6, CRP, Th1/Th2 Balance 14 days No
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