Effects of Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

Pancreaticoduodenectomy Clinical Trial

Official title:

Effects of Immunonutrition on Surgical Site Infection and Th1/Th2/Th17 Differentiation in Patients Undergoing Pancreaticoduodenectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00668876
• Other study ID #: furukawa2008
• 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

• Pancreaticoduodenectomy

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