Additional Effects Of Perioperative Immunonutrition In Patients Undergoing Pancreaticoduodenectomy

Study Overview

Additional Effects of Perioperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

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

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.

Pancreatic Tumor
Bile Duct Tumor

DIETARY_SUPPLEMENT: Oral IMPACT

AEPIPD

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2013-10-05	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-10-24
First Submitted that Met QC Criteria 2013-10-24	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-10-25
First Posted (ESTIMATED) 2013-10-25	Results First Posted N/A	Last Verified 2013-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Prevention

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Perioperative Oral IMPACT (1 L/day) for 5 days before surgery and by enteral feeding after surgery	DIETARY_SUPPLEMENT: Oral IMPACT Oral IMPACT enriched with arginine, omega-3 fatty acids, and RNA by enteral feeding after surgery
ACTIVE_COMPARATOR: Preoperative Oral IMPACT 1000ml/day for 5 days (1 L/day) before surgery	DIETARY_SUPPLEMENT: Oral IMPACT Oral IMPACT enriched with arginine, omega-3 fatty acids, and RNA by enteral feeding after surgery

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: Perioperative

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

DIETARY_SUPPLEMENT: Oral IMPACT

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

ACTIVE_COMPARATOR: Preoperative

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

DIETARY_SUPPLEMENT: Oral IMPACT

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

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

Secondary Outcome Measures	Measure Description	Time Frame
infectious complication rate		30 days

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Katsunori Furukawa, MD

Phone Number: +81-43-222-7171

Email: k-furukawa@umin.ac.jp

Study Contact Backup

Name: Daisuke Suzuki, MD

Phone Number: +81-43-222-7171

Email: d-suzuki@umin.ac.jp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

patients undergoing pancreaticoduodenectomy

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Katsunori Furukawa, MD, Chiba University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record