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Effects of Preoperative Immunonutrition in Patients Undergoing Hepatectomy

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ClinicalTrials.gov Identifier: NCT01256047
Recruitment Status : Unknown
Verified January 2014 by Katsunori Furukawa, Chiba University.
Recruitment status was:  Recruiting
First Posted : December 8, 2010
Last Update Posted : January 29, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Bile Duct Cancer Dietary Supplement: Oral IMPACT Phase 4

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of Preoperative Immunonutrition on Infectious Complication and Th1/Th2 Differentiation in Patients Undergoing Hepatectomy
Study Start Date : May 2009
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : March 2014

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. postoperative infectious complication [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. plasma IL-6, CRP, Th1/Th2 balance [ Time Frame: 14 days ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Katsunori Furukawa, MD, PhD, Chiba University
ClinicalTrials.gov Identifier: NCT01256047     History of Changes
Other Study ID Numbers: furukawa2009-2
First Posted: December 8, 2010    Key Record Dates
Last Update Posted: January 29, 2014
Last Verified: January 2014

Keywords provided by Katsunori Furukawa, Chiba University:
immunonutrition
hepatectomy
Th1
Th2

Additional relevant MeSH terms:
Bile Duct Neoplasms
Cholangiocarcinoma
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type