Unique ID issued by UMIN | UMIN000012231 |
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Receipt number | R000014243 |
Scientific Title | Phase 2 trial to evaluate immunomodulating diet enriched with whey peptide by perioperative administration in pancreatoduodenectomy for hepato-biliary-pancreatic malignancy |
Date of disclosure of the study information | 2013/12/01 |
Last modified on | 2013/11/07 15:26:18 |
Phase 2 trial to evaluate immunomodulating diet enriched with whey peptide by perioperative administration in pancreatoduodenectomy for hepato-biliary-pancreatic malignancy
NEW-PASSO
Phase 2 trial to evaluate immunomodulating diet enriched with whey peptide by perioperative administration in pancreatoduodenectomy for hepato-biliary-pancreatic malignancy
NEW-PASSO
Japan |
pancreas cancer,bile duct cancer, ampullary cancer
Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Malignancy
NO
The aim of this study is to evaluate whether perioperative administration of immunomodulating diet enriched with whey peptide could reduce the infectious and non-infectious complication after pancreaticoduodenectomy for hepato-biliary-pancreatic malignancy.
Efficacy
incidence of infectious/non-infectious complication
length of post-operative hospital stay
mortality rate
serum cytokine level etc.
Interventional
Parallel
Randomized
Open -no one is blinded
Placebo
2
Treatment
Medicine | Food |
Intervention:The volume of administrated immunomodulating diet is 600ml/day.
Intervention:The volume of administrated standard diet is 600ml/day.
18 | years-old | <= |
Not applicable |
Male and Female
Patients with pancreas,bile duct and ampullary cancer who will undergo pancreatoduodenectomy
Patients who cannot tolerate enteral nutrition and who have severe heart, respiratory, renal,liver dysfunction
and severe malnutrition are excluded.
100
1st name | |
Middle name | |
Last name | Junji Yamamoto |
National Defense Medical College Hospital
Department of Surgery
3-2, Namiki, Tokorozawa, Saitama
04-2995-1211
jyamamot@ndmc.ac.jp
1st name | |
Middle name | |
Last name | Tomoyuki Moriya |
National Defense Medical College Hospital
Department of Surgery
3-2, Namiki, Tokorozawa, Saitama
04-2995-1211
tmoriya@ndmc.ac.jp
Department of Surgery, National Defense Medical College
National Defense Medical College
NO
2013 | Year | 12 | Month | 01 | Day |
Unpublished
Enrolling by invitation
2012 | Year | 05 | Month | 01 | Day |
2012 | Year | 05 | Month | 01 | Day |
2013 | Year | 11 | Month | 07 | Day |
2013 | Year | 11 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014243
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