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CompletedNCT01256047Updated Feb 18, 2020

Effects of Preoperative Immunonutrition in Patients Undergoing Hepatectomy

A Phase 4 interventional study of Oral IMPACT in Bile Duct Cancer, sponsored by Chiba University. Completed at 1 site in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-18.

Sponsored by Chiba University · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Bile Duct Cancer

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Keywords

  • immunonutrition
  • hepatectomy
  • Th1
  • Th2
03

In context

Bile Duct Neoplasms

254 studies on the registry are indexed under Bile Duct Neoplasms; 44 are open to participants now.

This study's enrollment of 40 is below the median of 53 across 190 interventional studies indexed under Bile Duct Neoplasms.

Browse Bile Duct Neoplasms studies →

Lead sponsor

Chiba University is the lead sponsor of 17 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • hepatectomy

Exclusion criteria

Exclusion Criteria:

  • age younger than 18 years
  • ongoing infection
  • gastrointestinal obstruction
  • respiratory dysfunction
  • cardiac dysfunction
  • hepatic dysfunction
  • renal failure
  • history of recent or immunological disease
  • preoperative evidence of widespread disease
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    group A

    preoperative immunonutrition

    Dietary Supplement: Oral IMPACT

  • No intervention
    group B

    ordinary diet

Interventions

06

What researchers measure

Primary outcomes

  1. postoperative infectious complication

    Time frame: 30 days

Secondary outcomes

  1. plasma IL-6, CRP, Th1/Th2 balance

    Time frame: 14 days

07

Study locations

1 site
  • Chiba University
    Chiba, 260-8677, Japan
08

References and documents

Publications

  • 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. PubMed 26965712 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01256047
Lead sponsor
Chiba University
Responsible party
Katsunori Furukawa (MD, PhD, Chiba University) — Principal investigator
First posted
Dec 8, 2010
Start date
May 2009
Primary completion
Mar 2014
Completion
Mar 2014
Last update
Feb 18, 2020

Study contacts

Katsunori Furukawa, MD
study director · Chiba University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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