Unique ID issued by UMIN | UMIN000041399 |
---|---|
Receipt number | R000047262 |
Scientific Title | Intervention of personalized nutritional therapy to prevent dumping symptoms after gastrectomy |
Date of disclosure of the study information | 2020/09/15 |
Last modified on | 2020/08/12 19:25:14 |
Intervention of personalized nutritional therapy to prevent dumping symptoms after gastrectomy
Nutritional therapy to prevent dumping symptoms
Intervention of personalized nutritional therapy to prevent dumping symptoms after gastrectomy
Nutritional therapy to prevent dumping symptoms
Japan |
Dumping symptoms after radical gastrectomy
Gastrointestinal surgery |
Others
NO
To clarify the safety and efficacy of enteral nutrition to prevent dumping symptoms caused by blood glucose fluctuation after gastrectomy.
Safety,Efficacy
Exploratory
Phase II
Occurrence of dumping symptoms
Duration of hypoglycemia
Fluctuations in blood glucose
Compliance of enteral nutrition
Incidence of adverse events
Weight change
Changes in nutritional indice
Food intake
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Food |
Patients with dumping symptoms after distal gastrectomy wear a continuous blood glucose meter for 14 days. For 7 days, patients get enteral nutrition 200ml*2/day.
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1) Histologically diagnosed as gastric cancer
2) Radical resection was performed by distal gastrectomy (B-I reconstruction, RY reconstruction)
3) Three months or more after gastrectomy
4) Pathologically stageds as I or II
5) ECOG performance status score is 0-1
6) Able to fill out a questionnaire by themselves
7) Written informed consent
1) During chemotherapy (including postoperative adjuvant chemotherapy)
2) History of diabetes
3) Other enteral nutritional supplements and dietary supplements are used together
4) Some medical conditions that the investigator determines to be inappropriate.
20
1st name | Naoki |
Middle name | |
Last name | Hiki |
Kitasato University School of Medicine
Department of Upper Gastrointestinal Surgery
2520203
1-15-1 Kitasato, Minamiku, Sagamihara, Kanagawa, Japan
042-778-9974
nhiki@med.kitasato-u.ac.jp
1st name | Hideki |
Middle name | |
Last name | Ushiku |
Kitasato University School of Medicine
Department of Upper Gastrointestinal Surgery
2520203
1-15-1 Kitasato, Minamiku, Sagamihara, Kanagawa, Japan
042-778-9974
bridle_leather_0514@hotmail.com
Kitasato University School
Kitasato University School
Self funding
Kitasato University School
Kitasato University School of Medicine and Hospital Ethics Committee
1-15-1 Kitasato, Minamiku, Sagamihara, Kanagawa, Japan
042-778-8273
rinri-n@kitasato-u.ac.jp
NO
北里大学病院
2020 | Year | 09 | Month | 15 | Day |
Unpublished
Preinitiation
2020 | Year | 08 | Month | 11 | Day |
2020 | Year | 09 | Month | 15 | Day |
2021 | Year | 07 | Month | 31 | Day |
2020 | Year | 08 | Month | 12 | Day |
2020 | Year | 08 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047262