UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Usefulness of dexmedetomidine for endoscopic submucosal dissection in colon
Title of the study (Brief title)	Usefulness of dexmedetomidine for endoscopic submucosal dissection in colon
Region	Japan

Condition
Condition	colorectal tumor
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Usefulness of dexmedetomidine for endoscopic submucosal dissection in colon
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Satisfaction in patient
Key secondary outcomes	Patients' pain level (VAS) Endoscopists' satisfaction (VAS) Objective patients' pain level viewed from endoscopists (VAS) Movement (VAS) Difficulty (VAS) Rate of response Rate of en bloc Rate of R0 resection Resection time Resected section diameter Total amount of analgesic Rate of side effects Rate of complications

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	dexmedetomidine
Interventions/Control_2	placebo
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	18 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	1)Patients for whom ESD in colon will be performed 2)Patients who have provided written informed consent for participation in this study
Key exclusion criteria	Patients judged by the principal investigator or subinvestigator to be unsuitable for participation for any other reason (to ensure the safe conduct of this study)
Target sample size	80

Research contact person
Name of lead principal investigator	Hideaki Kinugasa
Organization	Hiroshima City Hiroshima Citizens Hospital
Division name	Internal medicine
Address	7-33 Motomachi, Naka-ku, Hiroshima-shi, Hiroshima-ken, Japan
TEL	082-221-2291
Email	gyacy14@gmail.com

Public contact
Name of contact person	Hideaki Kinugasa
Organization	Hiroshima City Hiroshima Citizens Hospital
Division name	Internal medicine
Address	7-33 Motomachi, Naka-ku, Hiroshima-shi, Hiroshima-ken, Japan
TEL	082-221-2291
Homepage URL
Email	gyacy14@gmail.com

Sponsor
Institute	Hiroshima City Hiroshima Citizens Hospital
Institute
Department

Funding Source
Organization	Hiroshima City Hiroshima Citizens Hospital
Organization
Division
Category of Funding Organization	Other
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	2016 Year 04 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 07 Day
Anticipated trial start date	2016 Year 04 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 04 Month 04 Day
Last modified on	2018 Year 01 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025056