Effects of Preoperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

Chiba University50 enrolled

Overview

The purpose of this study is to determine whether preoperative immunonutrition is effective on infectious complication and Th1/Th2 differentiation in patients with pancreaticoduodenectomy.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Pancreatic Cancer Bile Duct Cancer

Interventions

Oral IMPACTDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Chiba University

Chiba, Chiba, Japan

Outcomes

Primary Outcomes

Postoperative Infectious Complication

Time frame: 30 days

Secondary Outcomes

Plasma IL-6, CRP, Th1/Th2 Balance

Time frame: 14 days

Data from ClinicalTrials.gov

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