Additional Effects of Perioperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

Pancreatic Tumor Clinical Trial

Official title:

Additional Effects of Perioperative Immunonutrition on Th1/Th2 Differentiation in Patients Undergoing Pancreaticoduodenectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01969110
• Other study ID #: AEPIPD
• Status: Recruiting
• Phase: Phase 4
• First received: October 5, 2013
• Last updated: October 24, 2013
• Start date: January 2013
• Est. completion date: September 2015

Study information

• Verified date: October 2013
• Source: Chiba University
• Contact: Katsunori Furukawa, MD
• Phone: +81-43-222-7171
• Email: k-furukawa[@]umin.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bile Duct Neoplasms
• Bile Duct Tumor
• Pancreatic Neoplasms
• Pancreatic Tumor

Intervention

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

Locations

Country	Name	City	State
Japan	Chiba University Hospital	Chiba

Sponsors (1)

Lead Sponsor	Collaborator
Chiba University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma resolvin E1, cell-mediated immunity		30 days	No
Secondary	infectious complication rate		30 days	No