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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | preoperative immunonutrition |
|
| Group B | No Intervention | ordinary diet |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral IMPACT | Dietary Supplement | oral supplementation for 5 days (1L/day) before surgery of a formula enriched with arginine, omega-3 fatty acids, and RNA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Infectious Complication | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma IL-6, CRP, Th1/Th2 Balance | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katsunori Furukawa, MD | Chiba University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chiba University | Chiba | Chiba | 260-8670 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24589090 | Derived | Aida T, Furukawa K, Suzuki D, Shimizu H, Yoshidome H, Ohtsuka M, Kato A, Yoshitomi H, Miyazaki M. Preoperative immunonutrition decreases postoperative complications by modulating prostaglandin E2 production and T-cell differentiation in patients undergoing pancreatoduodenectomy. Surgery. 2014 Jan;155(1):124-33. doi: 10.1016/j.surg.2013.05.040. Epub 2013 Oct 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A | preoperative immunonutrition |
| FG001 | Group B | ordinary diet |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A | preoperative immunonutrition |
| BG001 | Group B | ordinary diet |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Postoperative Infectious Complication | Posted | Number | participants | 30 days |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A | preoperative immunonutrition |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Katsunori Furukawa | Chiba University Graduate School of Medicine | +81-43-226-2269 | k-furukawa@umin.ac.jp |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D001650 | Bile Duct Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D036881 | Long-Term Synaptic Depression |
| ID | Term |
|---|---|
| D009473 | Neuronal Plasticity |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Plasma IL-6, CRP, Th1/Th2 Balance | Not Posted | 14 days |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Group B | ordinary diet | 0 | 0 | 0 | 0 |
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001661 | Biliary Tract Neoplasms |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |