UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007984 |
|---|---|
| Receipt number | 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 17:18:49 |
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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
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
Sponsor or person
Institute
Kyoto Prefectural Yosanoumi Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009398
