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Effects of Preoperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

Effects of Preoperative Immunonutrition on Infectious Complication and Th1/Th2 Differentiation in Patients Undergoing Pancreaticoduodenectomy

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01256034
Acronym
EPIPD
Enrollment
50
Registered
2010-12-08
Start date
2009-05-31
Completion date
2012-03-31
Last updated
2012-10-23

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

Conditions

Pancreatic Cancer, Bile Duct Cancer

Keywords

immunonutrition, pancreaticoduodenectomy, Th1, Th2

Brief 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.

Detailed description

The investigators reported that preoperative immunonutrition improve the incidence of postoperative infectious complication in patients after pancreaticoduodenectomy, and modulation of Th1/Th2 differentiation may play important roles in this effect. Object of this study is to investigate the effects preoperative immunonutrition on incidence of postoperative infectious complication, and Th1/Th2 balance after pancreaticoduodenectomy.

Interventions

DIETARY_SUPPLEMENTOral IMPACT

oral supplementation for 5 days (1L/day) before surgery of a formula enriched with arginine, omega-3 fatty acids, and RNA

Sponsors

Chiba University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Postoperative Infectious Complication30 days

Secondary

MeasureTime frame
Plasma IL-6, CRP, Th1/Th2 Balance14 days

Countries

Japan

Participant flow

Participants by arm

ArmCount
Group A
preoperative immunonutrition
25
Group B
ordinary diet
25
Total50

Baseline characteristics

CharacteristicGroup ATotalGroup B
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
16 Participants30 Participants14 Participants
Age, Categorical
Between 18 and 65 years
9 Participants20 Participants11 Participants
Age Continuous66.4 years
STANDARD_DEVIATION 7.5
65.8 years
STANDARD_DEVIATION 8.5
65.1 years
STANDARD_DEVIATION 9.5
Region of Enrollment
Japan
25 participants50 participants25 participants
Sex: Female, Male
Female
5 Participants14 Participants9 Participants
Sex: Female, Male
Male
20 Participants36 Participants16 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Postoperative Infectious Complication

Time frame: 30 days

ArmMeasureValue (NUMBER)
Group APostoperative Infectious Complication7 participants
Group BPostoperative Infectious Complication15 participants
p-value: <0.05Chi-squared
Secondary

Plasma IL-6, CRP, Th1/Th2 Balance

Time frame: 14 days

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026