UMIN-CTR Clinical Trial

Basic information
Public title	Diagnostic usefulness of blue laser imaging with magnifying endoscopy for invasion depth of superficial esophageal squamous cell carcinoma.
Acronym	Diagnostic usefulness of blue laser imaging with magnifying endoscopy for invasion depth of superficial esophageal squamous cell carcinoma.
Scientific Title	Diagnostic usefulness of blue laser imaging with magnifying endoscopy for invasion depth of superficial esophageal squamous cell carcinoma.
Scientific Title:Acronym	Diagnostic usefulness of blue laser imaging with magnifying endoscopy for invasion depth of superficial esophageal squamous cell carcinoma.
Region	Japan

Condition
Condition	superficial esophageal squamous cell carcinoma.
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We aim to investigate the diagnostic value for invasion depth of superficial esophageal squamous cell carcinoma using magnifying endoscopy with blue laser imaging(BLI) by comparing that of narrow band imaging(NBI).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The diagnostic accuracy for invasion depth of SESCC using BLI with magnifying endoscopy.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
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Control
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Institution consideration
Blocking
Concealment

Intervention
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Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	the patients with superficial esophageal squamous cell carcinoma which are underwent endoscopic submucosal dissection.
Key exclusion criteria	1)the patients with the lesion which is not detected both BLI and NBI 2)the patients with the lesion which is not assessed both BLI and NBI 3)the patients who have been underwent radiotherapy for esophagus 4)the patients with the lesion whose microvascular pattern was not identified by magnifying endoscopy.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yuji Naito
Organization	Kyoto prefectural university of medicine
Division name	Gastroenterology and Hepatology
Zip code
Address	465, Kajii-cho, Kamigyo-ku, Kyoto 602-8566, Japan
TEL	0752515519
Email	ynaito@koto.kpu-m.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Tomohiro Ueda
Organization	Kyoto prefectural university of medicine
Division name	Gastroenterology and Hepatology
Zip code
Address	465, Kajii-cho, Kamigyo-ku, Kyoto 602-8566, Japan
TEL	0752515519
Homepage URL
Email	osamu-d@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto prefectural university of medicine
Institute
Department

Funding Source
Organization	Fujifilm Corporation
Organization
Division
Category of Funding Organization	Other
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IRB Contact (For public release)
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Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
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IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 27 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date	2017 Year 07 Month 01 Day
Last follow-up date
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Other

Other related information

Endoscopic images of superficial esophageal squamous cell carcinomas(SESCCs) were recorded by both magnifying endoscopy with narrow band imaging(M-NBI) and magnifying endoscopy with blue laser imaging(M-BLI) prior to ESD. SESCCs were pathologically diagnosed by ESD specimens. Three endoscopists with no information of the lesions evaluated invasion depth of SESCCs using M-BLI and M-NBI images according to JES classification. The diagnostic value of each procedure was evaluated.

Management information
Registered date	2017 Year 07 Month 27 Day
Last modified on	2017 Year 07 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031901

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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