Trial record 5 of 34 for:    Open Studies | "Bile Duct Neoplasms"

Additional Effects of Perioperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Chiba University
Sponsor:
Information provided by (Responsible Party):
Katsunori Furukawa, Chiba University
ClinicalTrials.gov Identifier:
NCT01969110
First received: October 5, 2013
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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
Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Chiba University:

Primary Outcome Measures:
  • plasma resolvin E1, cell-mediated immunity [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • infectious complication rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01969110

Contacts
Contact: Katsunori Furukawa, MD +81-43-222-7171 ext 72235 k-furukawa@umin.ac.jp
Contact: Daisuke Suzuki, MD +81-43-222-7171 ext 72234 d-suzuki@umin.ac.jp

Locations
Japan
Chiba University Hospital Recruiting
Chiba, Japan, 260-8670
Contact: Katsunori Furukawa, MD    +81-43-222-7171 ext 72235    k-furukawa@umin.ac.jp   
Sponsors and Collaborators
Chiba University
Investigators
Study Director: Katsunori Furukawa, MD Chiba University
  More Information

No publications provided

Responsible Party: Katsunori Furukawa, MD, PhD, Chiba University
ClinicalTrials.gov Identifier: NCT01969110     History of Changes
Other Study ID Numbers: AEPIPD
Study First Received: October 5, 2013
Last Updated: October 24, 2013
Health Authority: Japan: Institutional Review Board

Keywords provided by Chiba University:
Immunonutrition

Additional relevant MeSH terms:
Bile Duct Neoplasms
Pancreatic Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 20, 2014