Additional Effects of Perioperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

Phase 4

• Conditions: Pancreatic Tumor; Bile Duct Tumor
• Interventions: Dietary Supplement: Oral IMPACT

• Registration Number: NCT01969110
• Lead Sponsor: Chiba University

Brief 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.

Study Timeline

• Study Start: 2013-01
• Status Verified: 2013-10
• Study First Submitted: 2013-10-05
• Study First Submitted QC: 2013-10-24
• Last Update Submitted: 2013-10-24
• Study First Posted: 2013-10-25
• Last Update Posted: 2013-10-25
• Primary Completion: 2015-09
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Perioperative	Oral IMPACT	Oral IMPACT (1 L/day) for 5 days before surgery and by enteral feeding after surgery
Preoperative	Oral IMPACT	Oral IMPACT 1000ml/day for 5 days (1 L/day) before surgery

Primary Outcome Measures

Name	Time	Method
plasma resolvin E1, cell-mediated immunity	30 days

Secondary Outcome Measures

Name	Time	Method
infectious complication rate	30 days

Trial Locations

Locations (1)

Chiba University Hospital; 🇯🇵 Chiba, Japan