Additional Effects of Perioperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01969110

Enrollment

Registered

2013-10-25

Start date

2013-01-31

Completion date

2015-09-30

Last updated

2013-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Tumor, Bile Duct Tumor

Keywords

Immunonutrition

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.

Interventions

DIETARY_SUPPLEMENTOral IMPACT

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
plasma resolvin E1, cell-mediated immunity	30 days

Secondary

Measure	Time frame
infectious complication rate	30 days

Countries

Japan

Contacts

Primary ContactKatsunori Furukawa, MD

k-furukawa@umin.ac.jp+81-43-222-7171

Backup ContactDaisuke Suzuki, MD

d-suzuki@umin.ac.jp+81-43-222-7171

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026