Additional Effects of Perioperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy
Conditions
Pancreatic Tumor - Bile Duct Tumor
Conditions: official terms
Bile Duct Neoplasms - Pancreatic Neoplasms
Conditions: Keywords
Immunonutrition
Study Type
Interventional
Study Phase
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Intervention
Name: Oral IMPACT
Type: Dietary Supplement
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Both
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
Location
Chiba University Hospital
Chiba, Japan
Status: Recruiting
Contact: Katsunori Furukawa, MD - +81-43-222-7171 - k-furukawa@umin.ac.jp
Start Date
January 2013
Completion Date
September 2015
Sponsors
Chiba University
Source
Chiba University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page