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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013159
Receipt No. 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

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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
Email 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
Email t-iizuka@toranomon.gr.jp

Sponsor
Institute Department of Gastroenterology, Toranomon Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015245

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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