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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00668876
Other study ID # furukawa2008
Secondary ID
Status Completed
Phase Phase 4
First received April 28, 2008
Last updated December 2, 2008
Start date May 2006
Est. completion date September 2008

Study information

Verified date October 2008
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 immunonutrition is effective on surgical site infection and Th1/Th2/Th17 differentiation in patients undergoing pancreaticoduodenectomy


Description:

Perioperative immunonutrition is reported to improve the incidence of postoperative infectious complication in patients with gastrointestinal surgery. It has also been recognized that Th1/Th2 balance shifts toward Th2 by surgical stress. On the other hand, the change of Th17 status after surgery has not been established. Furthermore, The change of Th1/Th2 balance and Th17 status with immunonutrition on pancreaticoduodenectomy have not been reported yet.

Objective of this study is to investigate the effects of perioperative immunonutrition on incidence of postoperative infectious complication, Th1/Th2 balance and Th17 status after pancreaticoduodenectomy.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date September 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- patients underwent pancreaticoduodenectomy

Exclusion Criteria:

- age younger than 18 years or older than 75 years

- preoperative chemotherapy or radiation

- ongoing infection

- diabetes mellitus

- 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(1 L/d )before surgery of a formula enriched with arginine, omega-3 fatty acids, and RNA
Oral IMPACT
postoperative enteral infusion of the formula with arginine, omega-3 fatty acids, and RNA
Parenteral nutrition
Parenteral nutrition

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 surgical site infection after surgery 30days No
Secondary plasma IL-6, CRP, Th1/Th2 balance, Th17 status 14 days No
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