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Completed

NCT Number: NCT00668876

Effects of Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

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

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Key information

Conditions

Pancreaticoduodenectomy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chiba University

Chiba, 260-8670, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral IMPACT

Dietary Supplement

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

Other names: oral IMPACT; Ajinomoto Pharma Co., Ltd, Tokyo, Japan

parenteral nutrition

Dietary Supplement

Parenteral nutrition

Primary outcomes

  1. surgical site infection after surgery

    Time frame: 30days

Secondary outcomes

  1. plasma IL-6, CRP, Th1/Th2 balance, Th17 status

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Chiba University

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Apr 29, 2008
Registry last updated
Dec 3, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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