UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013159 |
|---|---|
| Receipt number | R000015245 |
| Scientific Title | Prospective evaluation of new sedative drug during ESD for esophageal cancer |
| Date of disclosure of the study information | 2014/02/14 |
| Last modified on | 2014/02/14 13:16:52 |
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Basic information
Public title
Prospective evaluation of new sedative drug during ESD for esophageal cancer
Acronym
Evaluation of new sedation
Scientific Title
Prospective evaluation of new sedative drug during ESD for esophageal cancer
Scientific Title:Acronym
Evaluation of new sedation
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy and safety of Precedex during ESD for esophageal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
body movement during ESD
Key secondary outcomes
1.the frequency of hypotention
2.the frequency of bradycardia
3.the frequency of respiratory depression
4.the frequency of complication due to ESD
5.the relationship between repiratory rate and saturation
6.awareness after ESD
7.the number of discontinuation of Precedex
8.sedative level during ESD
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Sedative status during ESD by administering Cercin and opistan
Interventions/Control_2
Sedative status during ESD by administering Precedex
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Squamous cell carcinoma histologically
2)SM2 or less tumor invasion as a preoperative diagnosis
3)no lymph node or distant metastasis by CT
4)obtained written informed consent
5)performance status is 0-2
6)no severe organ dysfunction
Key exclusion criteria
1)uncontrollable DM
2)uncontrollable HT
3)uncontrollable heart disease
4)severe or uncontroallable respiratory disease
5)acute alcoholoic addiction
6)epilepsy
7)oxygen is needed in walking or at rest
8)active bacterial of fungal infection
9)pregnancy
10)psychiatric disease
11)alcoholic liver cirrhosis
12)allergy to opistan
13)administered monoamin oxidase inhibitor
14)acute narrow-angle glaucoma
15)myasthenia gravis
16)administered ritonavir
Target sample size
104
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Misturu Kaise |
Organization
Toranomon Hospital
Division name
Department of Gastroenterology
Zip code
Address
2-2-2 toranomon Minato-ku Tokyo Japan
TEL
03-3588-1111
kaise@toranomon.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiro Iizuka |
Organization
Toranomon Hospital
Division name
Department of Gastroenterology
Zip code
Address
2-2-2 toranomon Minato-ku Tokyo Japan
TEL
03-3588-1111
Homepage URL
t-iizuka@toranomon.gr.jp
Sponsor or person
Institute
Department of Gastroenterology, Toranomon Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2014 | Year | 02 | Month | 14 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 14 | Day |
Last modified on
| 2014 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015245
