NCT01256047

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2010

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

4.8 years

First QC Date

December 7, 2010

Last Update Submit

February 16, 2020

Conditions

Bile Duct Cancer

Keywords

immunonutritionhepatectomyTh1Th2

Outcome Measures

Primary Outcomes (1)

  • postoperative infectious complication

    30 days

Secondary Outcomes (1)

  • plasma IL-6, CRP, Th1/Th2 balance

    14 days

Study Arms (2)

group A

ACTIVE COMPARATOR

preoperative immunonutrition

Dietary Supplement: Oral IMPACT

group B

NO INTERVENTION

ordinary diet

Interventions

Oral IMPACTDIETARY_SUPPLEMENT

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

Also known as: Oral IMPACT; Ajinomoto Pharma Co., Ltd, Tokyo, Japan
group A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hepatectomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chiba University

Chiba, 260-8677, Japan

Location

Related Publications (1)

  • 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.

    PMID: 26965712DERIVED

MeSH Terms

Conditions

Bile Duct Neoplasms

Interventions

Long-Term Synaptic Depression

Condition Hierarchy (Ancestors)

Biliary Tract NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsBile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Neuronal PlasticityNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Katsunori Furukawa, MD

    Chiba University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

December 7, 2010

First Posted

December 8, 2010

Study Start

May 1, 2009

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

February 18, 2020

Record last verified: 2020-02

Locations

JP(1)