UMIN-CTR Clinical Trial

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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