Effects of Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

Phase 4

Completed

• Conditions: Pancreaticoduodenectomy
• Interventions: Dietary Supplement: Oral IMPACT; Dietary Supplement: Parenteral nutrition

• Registration Number: NCT00668876
• Lead Sponsor: Chiba University

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2006-05
• Primary Completion: 2008-01
• Study First Submitted: 2008-04-28
• Study First Submitted QC: 2008-04-28
• Study First Posted: 2008-04-29
• Study Completion: 2008-09
• Status Verified: 2008-10
• Last Update Submitted: 2008-12-02
• Last Update Posted: 2008-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Oral IMPACT	Group A: perioperative immunonutrition
2	Oral IMPACT	Group B: postoperative immunonutrition
3	Parenteral nutrition	Group C: control

Primary Outcome Measures

Name	Time	Method
surgical site infection after surgery	30days

Secondary Outcome Measures

Name	Time	Method
plasma IL-6, CRP, Th1/Th2 balance, Th17 status	14 days

Trial Locations

Locations (1)

Chiba University; 🇯🇵 Chiba, Japan