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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021603
Receipt No. R000024913
Scientific Title Retrospective study of the relative merits of the image enhanced endoscope in the endoscopic diagnosis of early gastric cancer
Date of disclosure of the study information 2016/03/25
Last modified on 2016/09/26

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Basic information
Public title Retrospective study of the relative merits of the image enhanced endoscope in the endoscopic diagnosis of early gastric cancer
Acronym the relative merits of the image enhanced endoscope
Scientific Title Retrospective study of the relative merits of the image enhanced endoscope in the endoscopic diagnosis of early gastric cancer
Scientific Title:Acronym the relative merits of the image enhanced endoscope
Region
Japan

Condition
Condition early gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 It examines the visibility of superiority or inferiority of cancer in normal white light and the respective image enhanced endoscope using movie, aimed to reveal the appropriate selection and diagnostic methods of image enhanced endoscope.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visibility due to video
Key secondary outcomes Site and macroscopic type , size of cancer
Visibility of pathological diagnosis and the endoscope

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 The case what the video had been taken where was carried out EMR (endoscopic mucosal resection) or ESD (endoscopic gastric submucosal dissection) for the early gastric cancer or gastric adenoma at Kyoto Prefectural University of Medicine Hospital.
Key exclusion criteria
Cases principal investigator has determined to be inappropriate as a subject
Cases of age is less than 20 years old at the time of the endoscope underwent
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Naito
Organization Kyoto Prefectural University of Medicine Hospital
Division name Gastroenterology and Hepatology
Zip code
Address 465 Kaji-cho Kamijyo-ku Kyoto-si Kyoto-fu Japan
TEL 075-251-5519
Email syokanai@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Osamu Dohi
Organization Kyoto Prefectural University of Medicine University
Division name Gastroenterology and Hepatology
Zip code
Address 465 Kaji-cho Kamijyo-ku Kyoto-si Kyoto-fu Japan
TEL 075-251-5519
Homepage URL
Email osamu-d@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine University
Institute
Department

Funding Source
Organization Kyoto Prefectural University of Medicine University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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
2016 Year 03 Month 25 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
2015 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The case what the video that normal white light and the respective image enhanced endoscope (FICE, BLI, BLI-bright, LCI) had been taken where was carried out EMR (endoscopic mucosal resection) or ESD (endoscopic gastric submucosal dissection) for the early gastric cancer or gastric adenoma at Kyoto Prefectural University of Medicine Hospital. It examines the visibility of superiority or inferiority of cancer in normal white light and the respective image enhanced endoscope.

Management information
Registered date
2016 Year 03 Month 24 Day
Last modified on
2016 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024913

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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