UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008569
Receipt number 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 22:44:24

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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 or person

Institute

Department of Gastroenterology, Ishikawa Prefectural Central Hospital

Institute

Department

Personal name



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

Value
https://center6.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