UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004045 |
|---|---|
| Receipt number | R000004875 |
| Scientific Title | Clinical usefulness of magnifyiing endoscopy (ME) with narrow-band imaging (NBI) for screening endoscopy: a cost-effectiveness study |
| Date of disclosure of the study information | 2010/08/16 |
| Last modified on | 2014/02/16 23:04:25 |
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Basic information
Public title
Clinical usefulness of magnifyiing endoscopy (ME) with narrow-band imaging (NBI) for screening endoscopy: a cost-effectiveness study
Acronym
NBI routine study within the stomach
Scientific Title
Clinical usefulness of magnifyiing endoscopy (ME) with narrow-band imaging (NBI) for screening endoscopy: a cost-effectiveness study
Scientific Title:Acronym
NBI routine study within the stomach
Region
| Japan |
Condition
Condition
Gastaric cacner
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this sudy is to investigate tha advantage in cost-effectiveness of ME with NBI pver standard endoscoy with dye-splay.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Number of early gastric cancer/Number of lesions from which biopsies are taken
Key secondary outcomes
Sensitivity, specificity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Magnifying endoscopy with NBI and biopsy
Interventions/Control_2
Standard endoscopy and biopsy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patienss who receive screanig upper gastrointestinal endoscopy
Key exclusion criteria
1.The patient whose endoscopic diagnosis was already made
2. The patient which was diagnossed as advanced cancer
3. The patient whose biopsy was taken not for screening of carinoma
4. The patient who received sugcal resection of the stomach
5. The patients with severe underlying disease
6. The patient who is taking madicine which can cause bleeding tendency
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenshi Yao |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Enodoscopy
Zip code
Address
1-1-1 Zokumyoin, Chikushino-city, Fukuoka 818-8502, Japan
TEL
092-921-1011
yao@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenshi Yao |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Enodoscopy
Zip code
Address
1-1-1 Zokumyoin, Chikushino-city, Fukuoka 818-8502, Japan
TEL
092-921-1011
Homepage URL
yao@fukuoka-u.ac.jp
Sponsor or person
Institute
Grant for Multicenter Study
Institute
Department
Personal name
Funding Source
Organization
The Japanese Foundation for Research and Promotion of Endoscopy
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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 | 08 | 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
Completed
Date of protocol fixation
| 2009 | Year | 09 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 08 | Month | 16 | Day |
Last modified on
| 2014 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004875
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
