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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028840
Receipt No. R000033008
Scientific Title Efficacy of Endoscopy with linked color imaging (LCI) for superficial nonampullary duodenal epithelial tumor (SNADET)
Date of disclosure of the study information 2017/08/25
Last modified on 2019/02/11

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Basic information
Public title Efficacy of Endoscopy with linked color imaging (LCI) for superficial nonampullary duodenal epithelial tumor (SNADET)
Acronym LCI for SNADET
Scientific Title Efficacy of Endoscopy with linked color imaging (LCI) for superficial nonampullary duodenal epithelial tumor (SNADET)
Scientific Title:Acronym LCI for SNADET
Region
Japan

Condition
Condition Sporadic nonampullary duodenal adenoma/carcinoma
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To reveal the efficacy of endoscopy with LCI for SNADET
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes The Visibility score of endoscopy with LCI for SNADET, and the relationship between this and the score of endoscopy with WLI, BLI, and BLI bright
Key secondary outcomes The relationship between the Visibility score and patients characteristics (e.g. age, gender, and comorbidity), lesions characteristics (e.g. location, diameter, macroscopic appearance, and pathological findings) and objective assessment using graphics software

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 Patients with sporadic SNADET
Key exclusion criteria Patients with polyposis syndrome such as FAP, or evaluated incompetent by doctors in attendance
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Arai
Organization Chiba University Hospital
Division name Gastroenterology
Zip code
Address Department of Gastroenterology and Nephrology, Graduate School of Medicine, Chiba University (K1), 1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, 260-8670, Japan
TEL +81-43-226-2083
Email araim-cib@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Maruoka
Organization Chiba University Hospital
Division name Gastroenterology
Zip code
Address 1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, 260-8670, Japan
TEL +81-43-226-2083
Homepage URL
Email maruoka-cib@umin.ac.jp

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization Chiba University
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 千葉大学医学部附属病院(千葉県)

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 25 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 Enrolling by invitation
Date of protocol fixation
2017 Year 07 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Efficacy of endoscopy with LCI for SNADET will be analyzed.

Management information
Registered date
2017 Year 08 Month 25 Day
Last modified on
2019 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033008

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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