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NCT01256047 Clinical Trial

Effects of Preoperative Immunonutrition in Patients Undergoing Hepatectomy

Bile Duct Cancer Clinical Trial

Official title:
Effects of Preoperative Immunonutrition on Infectious Complication and Th1/Th2 Differentiation in Patients Undergoing Hepatectomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01256047
Other study ID # furukawa2009-2
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date May 2009
Est. completion date March 2014

Study information
Verified date February 2020
Source Chiba University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Japan Chiba University Chiba

Sponsors (1)
Lead Sponsor Collaborator
Chiba University

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary postoperative infectious complication 30 days
Secondary plasma IL-6, CRP, Th1/Th2 balance 14 days
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