Phase 4 N=50 Randomized Prevention

Effects of Preoperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

Pancreatic Cancer · Bile Duct Cancer

Bottom Line

View on ClinicalTrials.gov: NCT01256034 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Oct 2012

Primary outcome: Primary: Postoperative Infectious Complication — 7; 15 participants — p=<0.05

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Oral IMPACT (Dietary_supplement)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Chiba University
Primary completion: Mar 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Postoperative Infectious Complication	7; 15	<0.05 sig
SECONDARY Plasma IL-6, CRP, Th1/Th2 Balance	—	—

Summary

The purpose of this study is to determine whether preoperative immunonutrition is effective on infectious complication and Th1/Th2 differentiation in patients with pancreaticoduodenectomy.

Eligibility Criteria

Inclusion Criteria

patients underwent pancreaticoduodenectomy

Exclusion Criteria

age younger than 18 years
ongoing infection
gastrointestinal obstruction
respiratory dysfunction
cardiac dysfunction
hepatic dysfunction
renal failure
history of recent immunosuppressive or immunological diseases
preoperative evidence of widespread metastatic disease

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01256034). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.