UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized study evaluating antiperistaltic effect of L-menthol sprayed onto the colonic mucosa for colonic endoscopic mucosal resection in patients with no underlying disease
Title of the study (Brief title)	The RCT analyzing the efficacy of peppermint oil in colonic endoscopic mucosal resection in patients with no 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 scopolamine butylbromide in endoscopic mucosal resection for colorectal tumors in patients with no 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	Scopolamine butylbromide
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 scopolamine butylbromide 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	Kazuhiko Tokita
Organization	Kyoto Prefectural Yosanoumi Hospital
Division name	Department of Molecular Gastroenterology and Hepatology
Address	481, Otokoyama, Yosano-cho, Yosa county, Kyoto
TEL
Email

Public contact
Name of contact person	Ken Inoue
Organization	Kyoto Prefectural Yosanoumi Hospital
Division name	Department of Molecular Gastroenterology and Hepatology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 03 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000009396