UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The observational study on the safety of dexmedetomidine during endoscopic submucosal dissection for colorectal tumor
Title of the study (Brief title)	The observational study on the safety of dexmedetomidine during endoscopic submucosal dissection for colorectal tumor
Region	Japan

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

Objectives
Narrative objectives1	Evaluation of the safety of using dexmedetomidine as the intravenous anesthesia in endoscopic submucosal dissection for colorectal tumor
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Patient's circulation and Respiration during ESD for colorectal tumor
Key secondary outcomes	Evaluation of drug usage and sedation depth

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who will be performed ESD with colorectal tumor
Key exclusion criteria	Pregnant patients Patients with poor general condition Patients with serious cardiovascular or pulmonary disease, renal dysfunction and liver dysfunction.
Target sample size	80

Research contact person
Name of lead principal investigator	Hidemi Goto
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	65, Tsuruma-cho, Showa-ku, Nagoya
TEL	052-744-2172
Email	hgoto@med.nagoya-u.ac.jp

Public contact
Name of contact person	Hiroshi Oshima
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	65, Tsuruma-cho, Showa-ku, Nagoya
TEL	052-744-2172
Homepage URL
Email	h-oshima@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine, Department of Gastroenterology and Hepatology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Nagoya University Graduate School of Medicine, Department of Gastroenterology and Hepatology
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	2015 Year 07 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 01 Month 01 Day
Anticipated trial start date	2015 Year 07 Month 01 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	Evaluation of circulation, Respiration, drug usage and sedation depth, procedural accidents, and so on

Management information
Registered date	2014 Year 11 Month 28 Day
Last modified on	2016 Year 05 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018371