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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):
Katsunori Furukawa, Chiba University

December 7, 2010
December 8, 2010
January 29, 2014
May 2009
March 2014   (Final data collection date for primary outcome measure)
postoperative infectious complication [ Time Frame: 30 days ]
Same as current
Complete list of historical versions of study NCT01256047 on ClinicalTrials.gov Archive Site
plasma IL-6, CRP, Th1/Th2 balance [ Time Frame: 14 days ]
Same as current
Not Provided
Not Provided
 
Effects of Preoperative Immunonutrition in Patients Undergoing Hepatectomy
Effects of Preoperative Immunonutrition on Infectious Complication and Th1/Th2 Differentiation in Patients Undergoing Hepatectomy
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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Bile Duct Cancer
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
  • Active Comparator: group A
    preoperative immunonutrition
    Intervention: Dietary Supplement: Oral IMPACT
  • No Intervention: group B
    ordinary diet
Uno H, Furukawa K, Suzuki D, Shimizu H, Ohtsuka M, Kato A, Yoshitomi H, Miyazaki M. Immunonutrition suppresses acute inflammatory responses through modulation of resolvin E1 in patients undergoing major hepatobiliary resection. Surgery. 2016 Jul;160(1):228-236. doi: 10.1016/j.surg.2016.01.019. Epub 2016 Mar 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
40
20
March 2014
March 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01256047
furukawa2009-2
No
Not Provided
Not Provided
Katsunori Furukawa, Chiba University
Chiba University
Not Provided
Study Director: Katsunori Furukawa, MD Chiba University
Chiba University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP