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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008569
Receipt No. R000010065
Scientific Title Learning curve using e-learning system about magnifying narrow band imaging on endoscopic diagnosis of gastric lesion.A randomized study.
Date of disclosure of the study information 2012/08/13
Last modified on 2018/09/03

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Basic information
Public title Learning curve using e-learning system about magnifying narrow band imaging on endoscopic diagnosis of gastric lesion.A randomized study.
Acronym Learning curve of M-NBI stusy(NBI-LC study)
Scientific Title Learning curve using e-learning system about magnifying narrow band imaging on endoscopic diagnosis of gastric lesion.A randomized study.
Scientific Title:Acronym Learning curve of M-NBI stusy(NBI-LC study)
Region
Japan

Condition
Condition Gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the learning curve using e-learning system about magnifying narrow band imaging on endoscopic diagnosis of gastric lesion.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The difference of dianostic accuracy
Key secondary outcomes The difference of sensitivity, specificity, the rate of the grade classification, and the accuracy of VSCS

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Take the first test, and take the second test after e-learning for a term of one month, and take the third test after one month.
Interventions/Control_2 Take the first test, and take the second test after one month, and take the third test after e-learning for a term of one month.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Participating doctors will not be limited.
Key exclusion criteria nothing
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisashi doyama
Organization Ishikawa Prefectural Central Hospital
Division name Department of Gastroenterology
Zip code
Address Kuratsukihigashi 2-1, Kanazawa city, Ishikawa Prefecture
TEL 076-237-8211
Email doyama.134@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyoshi Nakanishi
Organization Ishikawa Prefectural Central Hospital
Division name Department of Gastroenterology
Zip code
Address Kuratsukihigashi 2-1, Kanazawa city, Ishikawa Prefecture
TEL 076-237-8211
Homepage URL
Email nakanishi.hry@gmail.com

Sponsor
Institute Department of Gastroenterology, Ishikawa Prefectural Central Hospital
Institute
Department

Funding Source
Organization The Japanese Foundation for Research and Promotion 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
2012 Year 08 Month 13 Day

Related information
URL releasing protocol
Publication of results Published

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
2013 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 01 Day
Last follow-up date
2015 Year 04 Month 30 Day
Date of closure to data entry
2015 Year 06 Month 25 Day
Date trial data considered complete
2015 Year 06 Month 25 Day
Date analysis concluded
2017 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 07 Month 30 Day
Last modified on
2018 Year 09 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010065

Research Plan
Registered date File name

Research case data specifications
Registered date File name
2015/06/25 150625NBI-LC study解析手順書UMINdocx.docx

Research case data
Registered date File name
2015/06/25 コピーe-learning 100問マラソン.xlsx


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