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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044219
Receipt No. R000050498
Scientific Title Evaluation of image enhancement for gastric cancer spraying l-menthol
Date of disclosure of the study information 2021/05/17
Last modified on 2021/05/15

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Basic information
Public title Evaluation of image enhancement for gastric cancer spraying l-menthol
Acronym Evaluation of image enhancement for gastric cancer spraying l-menthol
Scientific Title Evaluation of image enhancement for gastric cancer spraying l-menthol
Scientific Title:Acronym Evaluation of image enhancement for gastric cancer spraying l-menthol
Region
Japan

Condition
Condition gastric superficial tumor
Classification by specialty
Gastroenterology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate image enhancement of l-menthol with or without indigocarmine for gastric superficial neoplasia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Difference in border intelligibility before and after l-menthol spraying with and without indigocarmine
Key secondary outcomes

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 1 gastric lesions in the antrum
2 patients who receive endoscopy using l-menthol before ESD or surgery
Key exclusion criteria 1 allergy to menthol
2 allergy to indigocarmine
Target sample size 42

Research contact person
Name of lead principal investigator
1st name Shoko
Middle name
Last name Ono
Organization Hokkaido University Hospital
Division name Department of Gastroenterology
Zip code 0600808
Address W5,N14, Kita-ku, Sapporo
TEL +81117161161
Email onosho@med.hokudai.ac.jp

Public contact
Name of contact person
1st name Shoko
Middle name
Last name Ono
Organization Hokkaido University Hospital
Division name Department of Gastroenterology
Zip code 0608638
Address W5, N14, Kita-ku, Sapporo
TEL +81117161161
Homepage URL
Email onosho@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization Department of Gastroenterology, Hokkaido University 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 Hokkaido University IRB
Address W5, N-14, Kita-ku, Sapporo
Tel 011-706-7636
Email crjimu@huhp.hokudai.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 北海道大学病院

Other administrative information
Date of disclosure of the study information
2021 Year 05 Month 17 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
2021 Year 04 Month 15 Day
Date of IRB
2021 Year 04 Month 15 Day
Anticipated trial start date
2021 Year 05 Month 15 Day
Last follow-up date
2022 Year 08 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study using endoscopic images

Management information
Registered date
2021 Year 05 Month 15 Day
Last modified on
2021 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050498

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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