Effects of Preoperative Immunonutrition in Patients Undergoing Hepatectomy

NCT ID: NCT01256047

Last Updated: 2020-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2014-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bile Duct Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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group A

preoperative immunonutrition

Group Type ACTIVE_COMPARATOR

Oral IMPACT

Intervention Type DIETARY_SUPPLEMENT

oral supplement for 5 days(1L/day) before surgery of a formula enriched with arginine, omega-3 fatty acids, and RNA

group B

ordinary diet

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Oral IMPACT

oral supplement for 5 days(1L/day) before surgery of a formula enriched with arginine, omega-3 fatty acids, and RNA

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Oral IMPACT; Ajinomoto Pharma Co., Ltd, Tokyo, Japan

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chiba University

OTHER

Sponsor Role lead

Responsible Party

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Katsunori Furukawa

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katsunori Furukawa, MD

Role: STUDY_DIRECTOR

Chiba University

Locations

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Chiba University

Chiba, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 26965712 (View on PubMed)

Other Identifiers

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furukawa2009-2

Identifier Type: -

Identifier Source: org_study_id

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