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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040257
Receipt No. R000045925
Scientific Title Utility comparison test of super -magnifying endoscope for superficial duodenal epithetlial tumors (SDETs)
Date of disclosure of the study information 2020/05/01
Last modified on 2020/04/28

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Basic information
Public title Utility comparison test of super -magnifying endoscope for superficial duodenal epithetlial tumors (SDETs)
Acronym Utility comparison test of super -magnifying endoscope for superficial duodenal epithetlial tumors (SDETs)
Scientific Title Utility comparison test of super -magnifying endoscope for superficial duodenal epithetlial tumors (SDETs)
Scientific Title:Acronym Utility comparison test of super -magnifying endoscope for superficial duodenal epithetlial tumors (SDETs)
Region
Japan

Condition
Condition superficial duodenal epithetlial tumors (SDETs)
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Classification and evaluation of super-magnifying endoscopic observation for SDETs
Comparison of SDETs with normal duodenal mucosa.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Diagnostic ability and usefulness of super-magnifying endoscopic observation for SDETs.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Observation and image lesions by Olympus EC290.
Staining with Crystal violet and Methylene blue
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 who have SDETs at the age of 20 or older and are scheduled to undergo scrutiny and resection of lesions at our hospital.
Patients capable of pathological evaluation
Patients for whom consent was obtained for this study.
Patients judged appropriate by the practitioner.
Key exclusion criteria Patients under 20 years old.
Patients who have not obtained consent for this study.
Patients not judged appropriate by the practitioner.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Mitsuhiro
Middle name
Last name Fujishiro
Organization Nagoya University graduate school of medicine
Division name Department of Gastroenterology
Zip code 466-0065
Address 65, Tsurumai-cyo, Syowa-ku, Nagoya, Aichi, Japan
TEL 052-741-2172
Email mtfujish@gmail.com

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Hirose
Organization Nagoya University graduate school of medicine
Division name Department of Gastroenterology
Zip code 466-0065
Address 65, Tsurumai-cyo, Syowa-ku, Nagoya, Aichi, Japan
TEL 052-741-2172
Homepage URL
Email taka-h@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University graduate school of medicine, Department of Gastroenterology
Institute
Department

Funding Source
Organization none
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 Nagoya University Ethics Committee
Address 65, Tsurumai-cyo, Syowa-ku, Nagoya, Aichi, Japan
Tel 052-744-2061
Email ethics@med.nagoya-u.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
2020 Year 05 Month 01 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 Open public recruiting
Date of protocol fixation
2019 Year 12 Month 15 Day
Date of IRB
2018 Year 12 Month 14 Day
Anticipated trial start date
2019 Year 12 Month 15 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 04 Month 28 Day
Last modified on
2020 Year 04 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045925

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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