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Completed

NCT Number: NCT01256034

Effects of Preoperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

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

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Key information

Conditions

Pancreatic Cancer Bile Duct Cancer Bile Duct Diseases Bile Duct Neoplasms Biliary Tract Diseases Biliary Tract Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chiba University

Chiba, 260-8670, Japan

About this study

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.

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
  • 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

Treatment and study plan

Oral IMPACT

Dietary Supplement

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

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

Primary outcomes

  1. Postoperative Infectious Complication

    Time frame: 30 days

Secondary outcomes

  1. Plasma IL-6, CRP, Th1/Th2 Balance

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Chiba University

Other

Registry information

Official study title

Effects of Preoperative Immunonutrition on Infectious Complication and Th1/Th2 Differentiation in Patients Undergoing Pancreaticoduodenectomy

Acronym: EPIPD

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Dec 8, 2010
Registry last updated
Oct 23, 2012

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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