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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003339
Receipt No. R000003957
Scientific Title Prospective cohort study of procedures for ealry gastric cancer in the upper third of the stomach
Date of disclosure of the study information 2010/03/16
Last modified on 2015/07/10

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Basic information
Public title Prospective cohort study of procedures for ealry gastric cancer in the upper third of the stomach
Acronym Prospective cohort study of procedures for U-EGC
Scientific Title Prospective cohort study of procedures for ealry gastric cancer in the upper third of the stomach
Scientific Title:Acronym Prospective cohort study of procedures for U-EGC
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to evaluate the clinical effectivity of the procedures for early gastric cancer in the upper third of stomach.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary endpoint of this study was the rate of body weight loss one year after the operation.
Key secondary outcomes The secondary endpoints were the evaluations of clinical outcome including nutrition among three years, and the subjective evaluation at one year after from operation.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
0 years-old <=
Age-upper limit
999 years-old >
Gender Male and Female
Key inclusion criteria The inclusion criteria were as follows
1) initial therapy of the case of early gastric cancer in upper third of stomach
2) the case without esophageal invasion
3) including the cases with residual lesion after ESD or EMR treatment
4) the case should keep more than half of stomach after resection
5) the case without another malignant tumor
6) the case should survive for at least 3 years
7) the case signed informed consent
Key exclusion criteria The exclusion criteria was the cases whom the doctors define as inappropriate
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichiro Doki, MD
Organization Osaka University, Graduate School of Medicine
Division name Department of Gastroenterological Surgery
Zip code
Address 2-2-E2, Yamadaoka, Siuta, Osala, 565-0871, Japan
TEL 06-6879-3251
Email

Public contact
Name of contact person
1st name
Middle name
Last name Syuji Takiguchi
Organization Osaka University, Graduate School of Medicine
Division name Department of Gastroenterological Surgery
Zip code
Address
TEL 06-6879-3251
Homepage URL
Email

Sponsor
Institute Multicenter Clinical Study Group of Osaka
Institute
Department

Funding Source
Organization none(self funding)
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 16 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 No longer recruiting
Date of protocol fixation
2009 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 05 Month 01 Day
Last follow-up date
2015 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The aim of this study was to evaluate the difference of outcome after operation(TG or PG) for U-EGC. The case which can be perfomed TG or PG should be entered in this study. The patients choiced the procedure, and we follow them among three years and survay subjective evaluation by questionale one year after operation.

Management information
Registered date
2010 Year 03 Month 15 Day
Last modified on
2015 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003957

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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