Effects of Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00668876

Enrollment

Registered

2008-04-29

Start date

2006-05-31

Completion date

2008-09-30

Last updated

2008-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreaticoduodenectomy

Keywords

immunonutrition, pancreaticoduodenectomy, Th1, Th2, Th17

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.

Interventions

DIETARY_SUPPLEMENTOral IMPACT

oral supplementation for 5 days(1 L/d )before surgery of a formula enriched with arginine, omega-3 fatty acids, and RNA

DIETARY_SUPPLEMENTParenteral nutrition

Parenteral nutrition

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
surgical site infection after surgery	30days

Secondary

Measure	Time frame
plasma IL-6, CRP, Th1/Th2 balance, Th17 status	14 days

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026