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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007984
Receipt No. R000009398
Scientific Title Randomized study evaluating antiperistaltic effect of L-menthol sprayed onto the colonic mucosa for colonic endoscopic mucosal resection in patients with underlying disease
Date of disclosure of the study information 2012/05/18
Last modified on 2016/11/22

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Basic information
Public title Randomized study evaluating antiperistaltic effect of L-menthol sprayed onto the colonic mucosa for colonic endoscopic mucosal resection in patients with underlying disease
Acronym The RCT analyzing the efficacy of peppermint oil in colonic endoscopic mucosal resection in patients with underlying disease
Scientific Title Randomized study evaluating antiperistaltic effect of L-menthol sprayed onto the colonic mucosa for colonic endoscopic mucosal resection in patients with underlying disease
Scientific Title:Acronym The RCT analyzing the efficacy of peppermint oil in colonic endoscopic mucosal resection in patients with underlying disease
Region
Japan

Condition
Condition Colorectal tumors
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this RCT is to evaluate the antiperistaltic effect of L-menthol compared to glucagon in endoscopic mucosal resection for colorectal tumors in patients with underlying disease
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes The rate of endoscopic and histopathological enbloc resection
Key secondary outcomes The operation time and antiperistaltic effect

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 1.6% L-menthol
Interventions/Control_2 Glucagon
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 agreement to our study and undergo endoscopic mucosal resecton using 1.6% L-menthol or glucagon for colorectal tumors with 5mm to 20mm in diameter
Key exclusion criteria Patient who is not able to undergo colonic endoscopic mucosal resection by other organs disorder
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiko Tokita
Organization Kyoto Prefectural Yosanoumi Hospital
Division name Department of Molecular Gastroenterology and Hepatology
Zip code
Address 481, Otokoyama, Yosano-cho, Yosa county, Kyoto
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Ken Inoue
Organization Kyoto Prefectural Yosanoumi Hospital
Division name Department of Molecular Gastroenterology and Hepatology
Zip code
Address 481, Otokoyama, Yosano-cho, Yosa county, Kyoto
TEL
Homepage URL
Email

Sponsor
Institute Kyoto Prefectural Yosanoumi Hospital
Institute
Department

Funding Source
Organization Kyoto Prefectural Yosanoumi 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

Other administrative information
Date of disclosure of the study information
2012 Year 05 Month 18 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 03 Month 26 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
2014 Year 04 Month 01 Day
Date of closure to data entry
2014 Year 08 Month 01 Day
Date trial data considered complete
2014 Year 08 Month 01 Day
Date analysis concluded
2014 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 05 Month 18 Day
Last modified on
2016 Year 11 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009398

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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