Effects of Preoperative Immunonutrition in Patients Undergoing Hepatectomy

This study is currently recruiting participants.
Verified January 2014 by Chiba University
Sponsor:
Information provided by (Responsible Party):
Katsunori Furukawa, Chiba University
ClinicalTrials.gov Identifier:
NCT01256047
First received: December 7, 2010
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Bile Duct Cancer
Dietary Supplement: Oral IMPACT
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effects of Preoperative Immunonutrition on Infectious Complication and Th1/Th2 Differentiation in Patients Undergoing Hepatectomy

Resource links provided by NLM:


Further study details as provided by Chiba University:

Primary Outcome Measures:
  • postoperative infectious complication [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • plasma IL-6, CRP, Th1/Th2 balance [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2009
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: group A
preoperative immunonutrition
Dietary Supplement: Oral IMPACT
oral supplement for 5 days(1L/day) before surgery of a formula enriched with arginine, omega-3 fatty acids, and RNA
Other Name: Oral IMPACT; Ajinomoto Pharma Co., Ltd, Tokyo, Japan
No Intervention: group B
ordinary diet

Detailed Description:

The investigators reported that preoperative immunonutrition improve the incidence of postoperative infectious complication in patients after hepatectomy, and modulation of Th1/Th2 differentiation may play important roles in this effect.

Object of this study is to investigate the effects of preoperative immunonutrition on incidence of postoperative infectious complication, and Th1/Th2 balance after hepatectomy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • hepatectomy

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 disease
  • preoperative evidence of widespread metastatic disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01256047

Contacts
Contact: Katsunori Furukawa, MD +81-43-222-7171 ext 72235 k-furukawa@umin.ac.jp
Contact: Toshiaki Aida, MD +81-43-222-7171 ext 72236 aiaida@aol.com

Locations
Japan
Chiba University Recruiting
Chiba, Japan, 260-8677
Contact: Katsunori Furukawa, MD    +81-43-222-7171 ext 72235    k-furukawa@umin.ac.jp   
Contact: Toshiaki Aida, MD    +81-43-222-7171 ext 72236    aiaida@aol.com   
Principal Investigator: Katsunori Furukawa, MD         
Sponsors and Collaborators
Chiba University
Investigators
Study Director: Katsunori Furukawa, MD Chiba University
  More Information

No publications provided

Responsible Party: Katsunori Furukawa, MD, PhD, Chiba University
ClinicalTrials.gov Identifier: NCT01256047     History of Changes
Other Study ID Numbers: furukawa2009-2
Study First Received: December 7, 2010
Last Updated: January 28, 2014
Health Authority: Japan: Institutional Review Board

Keywords provided by Chiba University:
immunonutrition
hepatectomy
Th1
Th2

Additional relevant MeSH terms:
Bile Duct Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 16, 2014