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Effects of Preoperative Immunonutrition in Patients Undergoing Hepatectomy

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 25, 2014