UMIN-CTR Clinical Trial

Public title

Development of e-learning system for endoscopic diagnosis of gastric cancer: an international multicenter trial

Acronym

Global e-Endo Study Team (GEST)

Scientific Title

Development of e-learning system for endoscopic diagnosis of gastric cancer: an international multicenter trial

Scientific Title:Acronym

Global e-Endo Study Team (GEST)

Region

Asia(except Japan)	South America	Australia
Europe

Condition

Gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The development of an internet-based e-learning system for the detection of early gastric cancer, and evaluation of learning outcomes and clinical outcomes.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III

Primary outcomes

Internet-based e-tests are undertaken before and after e-learning in order to assess the primary endpoint of degree of improvement in test scores.

Key secondary outcomes

The difference between early gastric cancer detection rates in the pre-learning and post-learning periods comprises the secondary endpoint.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Maneuver

Interventions/Control_1

E-learning system

Interventions/Control_2

no

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) The supplied e-test and e-learning samples must display and operate correctly on the web browser on the participants' computer.
2) Participants must have sufficient English skills to understand the e-test and e-learning materials.
3) Participants must complete the pre questionnaire in full within a month.
4) Participants must submit a signed consent form for participation in the study.

Key exclusion criteria

This study is designed to evaluate the effectiveness (in terms of learning outcomes) of the e-learning system for medical practitioners who have not received adequate training in the endoscopic diagnosis of early gastric cancer. Accordingly, medical practitioners who score 80% or more on the pre-test will be excluded from the study.

Target sample size

200

Name of lead principal investigator

1st name
Middle name
Last name	Kenshi Yao

Organization

Fukuoka University, Fucaulty of Medicine

Division name

Department of Endoscopy, Fukuoka University Chikushi Hospital

Zip code

Address

1-1-1 Zokumyoin Chikushino-city

TEL

092-921-1011

Email

yao@fukuoka-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Hideki Ishikawa

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Molecular-Targeting Cancer Prevention

Zip code

Address

3-2-17 2F Imabashi Chyuo-ku Osaka-city, 541-0042, Japan

TEL

06-6202-5444

Homepage URL

Email

cancer@gol.com

Institute

Funds from the Central Research Institute of Fukuoka University (I)

Institute

Department

Personal name

Organization

Fukuoka University

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

03

Month

21

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

515 endoscopists from 35 countries were assessed for eligibility, and 332 were enrolled in the study, with 166 allocated to either e-learning or non-e-learning groups. Of these, 151 participants in the e-learning group and 144 in the non-e-earning group were included in the analysis. The mean improvement rate (standard deviation) in the elearning and non-e-learning groups was 1.24 (0.26) and 1.00 (0.16), respectively (P < 0.001).

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

Recruitment status

Main results already published

Date of protocol fixation

2012

Year

12

Month

20

Day

Date of IRB

Anticipated trial start date

2013

Year

03

Month

23

Day

Last follow-up date

2015

Year

03

Month

22

Day

Date of closure to data entry

2016

Year

03

Month

22

Day

Date trial data considered complete

2016

Year

03

Month

22

Day

Date analysis concluded

2016

Year

04

Month

22

Day

Other related information

Development of an e-learning system for the endoscopic diagnosis of early gastric cancer: an international multicenter randomized controlled trial
EBioMedicine 2016; 9: 140-147

Registered date

2013

Year

03

Month

20

Day

Last modified on

2017

Year

03

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012039