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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041399
Receipt No. 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

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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
Email 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
Email bridle_leather_0514@hotmail.com

Sponsor
Institute Kitasato University School
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047262

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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