NCT00668876

Brief Summary

The purpose of this study is to determine whether immunonutrition is effective on surgical site infection and Th1/Th2/Th17 differentiation in patients undergoing pancreaticoduodenectomy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2006

Typical duration 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, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 29, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

December 3, 2008

Status Verified

October 1, 2008

Enrollment Period

1.7 years

First QC Date

April 28, 2008

Last Update Submit

December 2, 2008

Conditions

Pancreaticoduodenectomy

Keywords

immunonutritionpancreaticoduodenectomyTh1Th2Th17

Outcome Measures

Primary Outcomes (1)

  • surgical site infection after surgery

    30days

Secondary Outcomes (1)

  • plasma IL-6, CRP, Th1/Th2 balance, Th17 status

    14 days

Study Arms (3)

1

ACTIVE COMPARATOR

Group A: perioperative immunonutrition

Dietary Supplement: Oral IMPACT

2

ACTIVE COMPARATOR

Group B: postoperative immunonutrition

Dietary Supplement: Oral IMPACT

3

ACTIVE COMPARATOR

Group C: control

Dietary Supplement: Parenteral nutrition

Interventions

Oral IMPACTDIETARY_SUPPLEMENT

oral supplementation for 5 days(1 L/d )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
1
Parenteral nutritionDIETARY_SUPPLEMENT

Parenteral nutrition

3

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients underwent pancreaticoduodenectomy

You may not qualify if:

  • age younger than 18 years or older than 75 years
  • preoperative chemotherapy or radiation
  • ongoing infection
  • diabetes mellitus
  • gastrointestinal obstruction
  • respiratory dysfunction
  • cardiac dysfunction
  • hepatic dysfunction
  • renal failure
  • history of recent immunosuppressive or immunological diseases
  • preoperative evidence of widespread metastatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chiba University

Chiba, Chiba, 260-8670, Japan

Location

MeSH Terms

Interventions

Long-Term Synaptic DepressionParenteral Nutrition

Intervention Hierarchy (Ancestors)

Neuronal PlasticityNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaFeeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • Daisuke Suzuki

    Chiba University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 28, 2008

First Posted

April 29, 2008

Study Start

May 1, 2006

Primary Completion

January 1, 2008

Study Completion

September 1, 2008

Last Updated

December 3, 2008

Record last verified: 2008-10

Locations

JP(1)