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Additional Effects of Perioperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2013 by Chiba University.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Katsunori Furukawa, Chiba University Identifier:
First received: October 5, 2013
Last updated: October 24, 2013
Last verified: October 2013
The purpose of this study is to investigate whether perioperative immunonutrition has additional effects on cell-mediated immunity in patients undergoing pancreaticoduodenectomy.

Condition Intervention Phase
Pancreatic Tumor
Bile Duct Tumor
Dietary Supplement: Oral IMPACT
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Additional Effects of Perioperative Immunonutrition on Th1/Th2 Differentiation in Patients Undergoing Pancreaticoduodenectomy

Further study details as provided by Chiba University:

Primary Outcome Measures:
  • plasma resolvin E1, cell-mediated immunity [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • infectious complication rate [ Time Frame: 30 days ]

Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Oral IMPACT; Ajinomoto Pharma Co., Ltd, Tokyo, Japan
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
Other Name: Oral IMPACT; Ajinomoto Pharma Co., Ltd, Tokyo, Japan

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.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01969110

Contact: Katsunori Furukawa, MD +81-43-222-7171 ext 72235
Contact: Daisuke Suzuki, MD +81-43-222-7171 ext 72234

Chiba University Hospital Recruiting
Chiba, Japan, 260-8670
Contact: Katsunori Furukawa, MD    +81-43-222-7171 ext 72235   
Sponsors and Collaborators
Chiba University
Study Director: Katsunori Furukawa, MD Chiba University
  More Information

Responsible Party: Katsunori Furukawa, MD, PhD, Chiba University Identifier: NCT01969110     History of Changes
Other Study ID Numbers: AEPIPD
Study First Received: October 5, 2013
Last Updated: October 24, 2013

Keywords provided by Chiba University:

Additional relevant MeSH terms:
Pancreatic Neoplasms
Bile Duct Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Biliary Tract Neoplasms
Bile Duct Diseases
Biliary Tract Diseases processed this record on April 25, 2017