UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021603 |
|---|---|
| Receipt number | 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 11:57:57 |
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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
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
osamu-d@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024913
