UMIN-CTR Clinical Trial
| 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 |
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Basic information
Public title
Intervention of personalized nutritional therapy to prevent dumping symptoms after gastrectomy
Acronym
Nutritional therapy to prevent dumping symptoms
Scientific Title
Intervention of personalized nutritional therapy to prevent dumping symptoms after gastrectomy
Scientific Title:Acronym
Nutritional therapy to prevent dumping symptoms
Region
| Japan |
Condition
Condition
Dumping symptoms after radical gastrectomy
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the safety and efficacy of enteral nutrition to prevent dumping symptoms caused by blood glucose fluctuation after gastrectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Occurrence of dumping symptoms
Key secondary outcomes
Duration of hypoglycemia
Fluctuations in blood glucose
Compliance of enteral nutrition
Incidence of adverse events
Weight change
Changes in nutritional indice
Food intake
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
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
Key exclusion criteria
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.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Hiki |
Organization
Kitasato University School of Medicine
Division name
Department of Upper Gastrointestinal Surgery
Zip code
2520203
Address
1-15-1 Kitasato, Minamiku, Sagamihara, Kanagawa, Japan
TEL
042-778-9974
nhiki@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Ushiku |
Organization
Kitasato University School of Medicine
Division name
Department of Upper Gastrointestinal Surgery
Zip code
2520203
Address
1-15-1 Kitasato, Minamiku, Sagamihara, Kanagawa, Japan
TEL
042-778-9974
Homepage URL
bridle_leather_0514@hotmail.com
Sponsor or person
Institute
Kitasato University School
Institute
Department
Personal name
Funding Source
Organization
Kitasato University School
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Kitasato University School
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University School of Medicine and Hospital Ethics Committee
Address
1-15-1 Kitasato, Minamiku, Sagamihara, Kanagawa, Japan
Tel
042-778-8273
rinri-n@kitasato-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
北里大学病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2020 | Year | 08 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 12 | Day |
Last modified on
| 2020 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047262
