Unique ID issued by UMIN | UMIN000023455 |
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Receipt number | R000027026 |
Scientific Title | Study of long-run effect of early nutritional intervention with an elemental diet (ELEMENTAL) for gastric cancer patients after surgical treatment as an accompanying research of KSES001. |
Date of disclosure of the study information | 2016/08/04 |
Last modified on | 2020/03/13 17:44:18 |
Study of long-run effect of early nutritional intervention with an elemental diet (ELEMENTAL) for gastric cancer patients after surgical treatment as an accompanying research of KSES001.
Study of long-run effect of early nutritional intervention with an elemental diet (ELEMENTAL) for gastric cancer patients after surgical treatment as an accompanying research of KSES001.
Study of long-run effect of early nutritional intervention with an elemental diet (ELEMENTAL) for gastric cancer patients after surgical treatment as an accompanying research of KSES001.
Study of long-run effect of early nutritional intervention with an elemental diet (ELEMENTAL) for gastric cancer patients after surgical treatment as an accompanying research of KSES001.
Japan |
Gastric Cancer
Gastrointestinal surgery |
Malignancy
NO
The study is performed to examine the inhibiting effect of weight loss after one year from the early nutritional intervention with an elemental diet by study of KSES001 and these patients are randomly assigned to ED group or control group.
UMIN000008056
Efficacy
Exploratory
Pragmatic
Not applicable
Rate of body weight loss from before the surgery to half a year and one year after the surgery, respectively.
(1) Area of skeletal muscle, maximum area of psoas major muscle, capacity of psoas major muscle, rate of skeletal muscle mass (corrected value)
(2) Implementation status of the adjuvant chemotherapy
(3) Period of duration after the adjuvant chemotherapy
(4) Laboratory values
(5) Existence or non-existence of relapse
(6) Intake of elemental diet, oligomeric formula and polymeric formula
(7) Late complications after surgery
Observational
20 | years-old | <= |
Not applicable |
Male and Female
Patients registered as key inclusion criteria of KSES001. Concretely, cases registered as KSES001 among those of the non-preoperative therapy and Gastric cancer those with Stage I, II or III undergo R0 surgery (TG surgery or DG surgery) from September, 2011 to June, 2012.
There is none of new key exclusion criteria because the patients of KSES001 are selected in this study.
108
1st name | |
Middle name | |
Last name | Yutaka Kimura |
Kindai University
Surgery
377-2,Oonohigashi, Osakasayama-shi, Osaka
072-366-0221
you-kimura@surg.med-kindai.ac.jp
1st name | |
Middle name | |
Last name | Yutaka Kimura |
Kindai University
Surgery
377-2,Oonohigashi, Osakasayama-shi, Osaka
072-366-0221
you-kimura@surg.med-kindai.ac.jp
KSES
EA Pharma Co., Ltd.
Self funding
NO
2016 | Year | 08 | Month | 04 | Day |
Unpublished
Completed
2016 | Year | 03 | Month | 05 | Day |
2012 | Year | 02 | Month | 02 | Day |
2016 | Year | 03 | Month | 05 | Day |
2017 | Year | 12 | Month | 31 | Day |
Multicenter observational study
2016 | Year | 08 | Month | 03 | Day |
2020 | Year | 03 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027026
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