UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003339 |
|---|---|
| Receipt number | 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 10:23:45 |
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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
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
Sponsor or person
Institute
Multicenter Clinical Study Group of Osaka
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
