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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004045
Receipt No. 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

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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
Email 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
Email yao@fukuoka-u.ac.jp

Sponsor
Institute Grant for Multicenter Study
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004875

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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