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Additional Effects of Perioperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

NCT ID: NCT01969110

Last Updated: 2013-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-09-30

Brief Summary

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The purpose of this study is to investigate whether perioperative immunonutrition has additional effects on cell-mediated immunity in patients undergoing pancreaticoduodenectomy.

Detailed Description

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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.

Conditions

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Pancreatic Tumor Bile Duct Tumor

Keywords

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Immunonutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Perioperative

Oral IMPACT (1 L/day) for 5 days before surgery and by enteral feeding after surgery

Group Type ACTIVE_COMPARATOR

Oral IMPACT

Intervention Type DIETARY_SUPPLEMENT

Oral IMPACT enriched with arginine, omega-3 fatty acids, and RNA by enteral feeding after surgery

Preoperative

Oral IMPACT 1000ml/day for 5 days (1 L/day) before surgery

Group Type ACTIVE_COMPARATOR

Oral IMPACT

Intervention Type DIETARY_SUPPLEMENT

Oral IMPACT enriched with arginine, omega-3 fatty acids, and RNA by enteral feeding after surgery

Interventions

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Oral IMPACT

Oral IMPACT enriched with arginine, omega-3 fatty acids, and RNA by enteral feeding after surgery

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Oral IMPACT; Ajinomoto Pharma Co., Ltd, Tokyo, Japan

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chiba University

OTHER

Sponsor Role lead

Responsible Party

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Katsunori Furukawa

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katsunori Furukawa, MD

Role: STUDY_DIRECTOR

Chiba University

Locations

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Chiba University Hospital

Chiba, Chiba, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Katsunori Furukawa, MD

Role: CONTACT

Phone: +81-43-222-7171

Email: [email protected]

Daisuke Suzuki, MD

Role: CONTACT

Phone: +81-43-222-7171

Email: [email protected]

Facility Contacts

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Katsunori Furukawa, MD

Role: primary

Other Identifiers

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AEPIPD

Identifier Type: -

Identifier Source: org_study_id