UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Retrospective study of the relative merits of the image enhanced endoscope in the endoscopic diagnosis of early gastric cancer
Title of the study (Brief title)	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	Yuji Naito
Organization	Kyoto Prefectural University of Medicine Hospital
Division name	Gastroenterology and Hepatology
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	Osamu Dohi
Organization	Kyoto Prefectural University of Medicine University
Division name	Gastroenterology and Hepatology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000024913