Effects of Immunonutrition in Patients Undergoing Pancrea... | NCT00668876

Studies
Effects of Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

NCT00668876

Sponsor

Chiba University

Status

Completed

Last Update Posted

Dec 3, 2008Estimated

Enrollment

30Actual

Phase

Phase 4

Conditions

Pancreaticoduodenectomy

Interventions

Oral IMPACT
Oral IMPACT
Parenteral nutrition

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2006

Primary Completion Date

Jan 2008Actual

Completion Date

Sep 2008Actual

First Submitted Date

Apr 28, 2008

First Submission Date that Met QC Criteria

Apr 28, 2008

First Posted Date

Apr 29, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2008

Last Update Posted Date

Dec 3, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Perioperative immunonutrition is reported to improve the incidence of postoperative infectious complication in patients with gastrointestinal surgery. It has also been recognized that Th1/Th2 balance shifts toward Th2 by surgical stress. On the other hand, the change of Th17 status after surgery has not been established. Furthermore, The change of Th1/Th2 balance and Th17 status with immunonutrition on pancreaticoduodenectomy have not been reported yet.

Objective of this study is to investigate the effects of perioperative immunonutrition on incidence of postoperative infectious complication, Th1/Th2 balance and Th17 status after pancreaticoduodenectomy.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Oral IMPACT	Dietary Supplement	oral supplementation for 5 days(1 L/d )before surgery of a formula enriched with arginine, omega-3 fatty acids, and RNA	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
surgical site infection after surgery		30days

Secondary Outcomes

Measure	Description	Time Frame
plasma IL-6, CRP, Th1/Th2 balance, Th17 status		14 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients underwent pancreaticoduodenectomy

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daisuke Suzuki	Chiba University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chiba University		Chiba	Chiba	260-8670	Japan

Intervention Browse Module

MeSH Terms

ID	Term
D036881	Long-Term Synaptic Depression
D010288	Parenteral Nutrition

Ancestor Terms

ID	Term
D009473	Neuronal Plasticity
D009424	Nervous System Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena
D005248	Feeding Methods

Browse Leaves

Not provided

Browse Branches

Not provided