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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028401
Receipt No. R000031901
Scientific Title Diagnostic usefulness of blue laser imaging with magnifying endoscopy for invasion depth of superficial esophageal squamous cell carcinoma.
Date of disclosure of the study information 2017/07/27
Last modified on 2017/07/27

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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
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 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
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
2017 Year 07 Month 27 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 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
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
Registered date File name

Research case data
Registered date File name


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