A Phase 4 interventional study of Oral IMPACT in Pancreatic Cancer and Bile Duct Cancer, sponsored by Chiba University. Completed at 1 site in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-10-23.
Sponsored by Chiba University · Phase 4, Interventional, and Prevention
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.
217 studies on the registry are indexed under Bile Duct Neoplasms; 43 are open to participants now.
This study's enrollment of 50 is close to the median of 50 across 161 interventional studies indexed under Bile Duct Neoplasms.
Browse Bile Duct Neoplasms studies →Chiba University is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
preoperative immunonutrition
Dietary Supplement: Oral IMPACT
ordinary diet
oral supplementation for 5 days (1L/day) before surgery of a formula enriched with arginine, omega-3 fatty acids, and RNA
Also known as: Oral IMPACT; Ajinomoto Pharma Co., Ltd, Tokyo, Japan
Postoperative Infectious Complication
Time frame: 30 days
Plasma IL-6, CRP, Th1/Th2 Balance
Time frame: 14 days
| Milestone | Group A | Group B |
|---|---|---|
| Started | 25 | 25 |
| Completed | 0 | 0 |
| Not completed | 25 | 25 |
| participants | Group A | Group B |
|---|---|---|
| Postoperative Infectious Complication | 7 | 15 |
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group A | — | — | — |
| Group B | — | — | — |
| Age, Categorical(Participants) | Group A | Group B | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 9 | 11 | 20 |
| >=65 years | 16 | 14 | 30 |
| Age Continuous(years) | Group A | Group B | Total |
|---|---|---|---|
| Mean | 66.4 ± 7.5 | 65.1 ± 9.5 | 65.8 ± 8.5 |
| Sex: Female, Male(Participants) | Group A | Group B | Total |
|---|---|---|---|
| Female | 5 | 9 | 14 |
| Male | 20 | 16 | 36 |
| Region of Enrollment(participants) | Group A | Group B | Total |
|---|---|---|---|
| Japan | 25 | 25 | 50 |
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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Chiba University