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2009-05
2012-03
2012-03
50
NCT01256034
Chiba University
Chiba University
INTERVENTIONAL
Effects of Preoperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy
The purpose of this study is to determine whether preoperative immunonutrition is effective on infectious complication and Th1/Th2 differentiation in patients with pancreaticoduodenectomy.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2010-12-07 | 2012-09-24 | 2012-09-24 |
2010-12-07 | 2012-09-24 | 2012-10-23 |
2010-12-08 | 2012-10-23 | 2012-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Prevention
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: Group A preoperative immunonutrition | DIETARY_SUPPLEMENT: Oral IMPACT
|
| NO_INTERVENTION: Group B ordinary diet |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Postoperative Infectious Complication | 30 days |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Plasma IL-6, CRP, Th1/Th2 Balance | 14 days |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
