Additional Effects of Perioperative Immunonutrition in Pa... | NCT01969110

Studies
Additional Effects of Perioperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

NCT01969110

Sponsor

Chiba University

Status

Unknown status

Last Update Posted

Oct 25, 2013Estimated

Enrollment

60Estimated

Phase

Phase 4

Conditions

Pancreatic Tumor
Bile Duct Tumor

Interventions

Oral IMPACT

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 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Sep 2015Estimated

Completion Date

Sep 2015Estimated

First Submitted Date

Oct 5, 2013

First Submission Date that Met QC Criteria

Oct 24, 2013

First Posted Date

Oct 25, 2013Estimated

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

Oct 24, 2013

Last Update Posted Date

Oct 25, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 investigate whether perioperative immunonutrition has additional effects on cell-mediated immunity in patients undergoing pancreaticoduodenectomy.

Detailed Description

The investigators reported that perioperative immunonutrition had no additional effects compared with preoperative immunonutrition in patients underwent colorectal surgery (Braga M, Gianotti L, Vignali A, Carlo VD. Preoperative oral arginine and n-3 fatty acid supplementation improves the immunometabolic host response and outcome after colorectal resection for cancer. Surgery. 2002; 132:805-14, PMID: 12464864). Object of this study is to investigate the additional effects of perioperative immunonutrition on cell-mediated immunity and incidence of infectious complication 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

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Perioperative	Active Comparator	Oral IMPACT (1 L/day) for 5 days before surgery and by enteral feeding after surgery	Dietary Supplement: Oral IMPACT
Preoperative	Active Comparator	Oral IMPACT 1000ml/day for 5 days (1 L/day) before surgery	Dietary Supplement: Oral IMPACT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oral IMPACT	Dietary Supplement	Oral IMPACT enriched with arginine, omega-3 fatty acids, and RNA by enteral feeding after surgery	Perioperative Preoperative

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
plasma resolvin E1, cell-mediated immunity		30 days

Secondary Outcomes

Measure	Description	Time Frame
infectious complication rate		30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients undergoing pancreaticoduodenectomy

Exclusion Criteria:

age younger than 18 years old
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Katsunori Furukawa, MD	Contact	+81-43-222-7171	72235	k-furukawa@umin.ac.jp
Daisuke Suzuki, MD	Contact	+81-43-222-7171	72234	d-suzuki@umin.ac.jp

Overall Officials

Name	Affiliation	Role
Katsunori Furukawa, MD	Chiba University	Study Director

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms
D001650	Bile Duct Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D036881	Long-Term Synaptic Depression

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided