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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000015786
Receipt No. R000018371
Scientific Title The observational study on the safety of dexmedetomidine during endoscopic submucosal dissection for colorectal tumor
Date of disclosure of the study information 2015/07/01
Last modified on 2016/05/30

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Basic information
Public title The observational study on the safety of dexmedetomidine during endoscopic submucosal dissection for colorectal tumor
Acronym The observational study on the safety of dexmedetomidine during endoscopic submucosal dissection for colorectal tumor
Scientific Title The observational study on the safety of dexmedetomidine during endoscopic submucosal dissection for colorectal tumor
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Hidemi Goto
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 65, Tsuruma-cho, Showa-ku, Nagoya
TEL 052-744-2172
Email hgoto@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Oshima
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
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

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)

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
2015 Year 07 Month 01 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 Terminated
Date of protocol fixation
2015 Year 01 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000018371

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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