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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023596
Receipt No. R000013022
Scientific Title Randomized study for the diagnosis of early esophageal cancer using the blue laser imaging endoscopy
Date of disclosure of the study information 2016/08/15
Last modified on 2019/03/13

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Basic information
Public title Randomized study for the diagnosis of early esophageal cancer using the blue laser imaging endoscopy
Acronym Randomized study for the diagnosis of early esophageal cancer using BLI endoscopy
Scientific Title Randomized study for the diagnosis of early esophageal cancer using the blue laser imaging endoscopy
Scientific Title:Acronym Randomized study for the diagnosis of early esophageal cancer using BLI endoscopy
Region
Japan

Condition
Condition Esophageal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the usefulness of magnifying endoscopy using blue laser imaging for detection of early esophageal squamous cell carcinoma compared with narrow band imaging
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes compare the detection ability of early esophageal squamous cell carcinoma in narrow band imaging and blue laser imaging
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 White light and NBI study
Interventions/Control_2 White light and BLI study
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
89 years-old >=
Gender Male and Female
Key inclusion criteria current or previous head and neck cancer or
previous (moreover six months before) superficial esophageal cancer
Informed consent was obtained
Key exclusion criteria esophageal adenocarcinoma
allergies of iodine
medication of anticoagulant
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Tatsuyuki
Middle name
Last name Kawano
Organization Tokyo Medical and Dental University
Division name Gastrointestinal surgery
Zip code 113-8519
Address Yushima 1-5-45, Bunkyoku, Tokyo, Japan
TEL 03-5803-5254
Email kawano.srg1@tmd.ac.jp

Public contact
Name of contact person
1st name kenro
Middle name
Last name kawada
Organization Tokyo Medical and Dental University
Division name Gastrointestinal surgery
Zip code 113-8519
Address Yushima
TEL 03-5803-5254
Homepage URL
Email kawada.srg1@tmd.ac.jp

Sponsor
Institute TokyoMedical and dental universit
Institute
Department

Funding Source
Organization none
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 Department of gastrointestinal surgery, Tokyo medical and dental university
Address Yushima 1-5-45, Bunkyoku, Tokyo ,Japan
Tel 0358035254
Email kawano.srg1@tmd.ac.jp

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 08 Month 15 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 513
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
2013 Year 05 Month 08 Day
Date of IRB
2013 Year 04 Month 30 Day
Anticipated trial start date
2013 Year 05 Month 27 Day
Last follow-up date
2017 Year 04 Month 01 Day
Date of closure to data entry
2019 Year 03 Month 12 Day
Date trial data considered complete
2019 Year 03 Month 13 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 08 Month 12 Day
Last modified on
2019 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013022

Research Plan
Registered date File name
2019/03/13 実施計画書2013.doc

Research case data specifications
Registered date File name
2019/03/13 NBI・BLI研究概要.pptx

Research case data
Registered date File name
2019/03/13 NBI-BLI study data固定.xlsx


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