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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012097
Receipt No. R000014135
Scientific Title A prospective randomized study to compare the tolerability of the magnifying narrow-band imaging endoscopy with lugol chromoendoscopy for esophageal cancer screening
Date of disclosure of the study information 2013/10/22
Last modified on 2014/04/22

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Basic information
Public title A prospective randomized study to compare the tolerability of the magnifying narrow-band imaging endoscopy with lugol chromoendoscopy for esophageal cancer screening
Acronym A prospective randomized study to compare the tolerability of the magnifying narrow-band imaging endoscopy with lugol chromoendoscopy for esophageal cancer screening
Scientific Title A prospective randomized study to compare the tolerability of the magnifying narrow-band imaging endoscopy with lugol chromoendoscopy for esophageal cancer screening
Scientific Title:Acronym A prospective randomized study to compare the tolerability of the magnifying narrow-band imaging endoscopy with lugol chromoendoscopy for esophageal cancer screening
Region
Japan

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

Objectives
Narrative objectives1 To compare the adverse symptoms of the magnifying narrow-band imaging endoscopy with lugol chromoendoscopy for esophageal cancer screening
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Visual analogue scale for heartburn after the examination
Key secondary outcomes Visual analogue scale for retrosternal pain or dyspnea after the examination

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 magnifying narrow-band imaging endoscopy
Interventions/Control_2 lugol chromoendoscopy
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who have more than six points in health risk appraisal-flushing score for esophageal cancer or patients who have history of head and neck squamous cell carcinoma
Key exclusion criteria 1)patients with iodine allergy
2)patients with severe organ failure
3)patients who have been judged as inappropriate for this study
Target sample size 52

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryuta Takenaka
Organization Tsuyama central hospital
Division name Department of Gastroenterology
Zip code
Address 1756, Kawasaki, Tsuyama, Okayama, Japan
TEL 0868-21-8111
Email rtakenak@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yasushi Yamasaki
Organization Tsuyama central hospital
Division name Department of Gastroenterology
Zip code
Address 1756, Kawasaki, Tsuyama, Okayama, Japan
TEL 0868-21-8111
Homepage URL
Email yasshifive@yahoo.co.jp

Sponsor
Institute Tsuyama central hospital
Institute
Department

Funding Source
Organization Tsuyama central hospital
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
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 津山中央病院(岡山県)

Other administrative information
Date of disclosure of the study information
2013 Year 10 Month 22 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
2012 Year 02 Month 03 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 21 Day
Last follow-up date
2015 Year 03 Month 21 Day
Date of closure to data entry
2015 Year 03 Month 21 Day
Date trial data considered complete
2015 Year 03 Month 21 Day
Date analysis concluded
2015 Year 03 Month 21 Day

Other
Other related information

Management information
Registered date
2013 Year 10 Month 22 Day
Last modified on
2014 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014135

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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