UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013601 |
|---|---|
| Receipt number | R000015889 |
| Scientific Title | Safe and effective sedation in endoscopic submucosal dissection for superficial esophageal squamous cell carcinoma: a randomized comparsion between propofol and midazolam. |
| Date of disclosure of the study information | 2014/04/03 |
| Last modified on | 2016/01/15 21:12:56 |
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Basic information
Public title
Safe and effective sedation in endoscopic submucosal dissection for superficial esophageal squamous cell carcinoma: a randomized comparsion between propofol and midazolam.
Acronym
Propofol vs midazolam for sedation in endoscopic submucosal dissection for superficial esophageal squamous cell carcinoma.
Scientific Title
Safe and effective sedation in endoscopic submucosal dissection for superficial esophageal squamous cell carcinoma: a randomized comparsion between propofol and midazolam.
Scientific Title:Acronym
Propofol vs midazolam for sedation in endoscopic submucosal dissection for superficial esophageal squamous cell carcinoma.
Region
| Japan |
Condition
Condition
superficial esophageal squamous cell carcinoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To estimate the safety and efficacy of the sedation with propofol or midazolam in endoscopic submucosal dissection for superficial esophageal squamous cell carcinoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
therapeutic interruption rate
Key secondary outcomes
therapeutic achievement rate
treatment time
adverse event
risk factors for a poor response to sedation
recovery time
satisfaction
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
propofol sedation
Interventions/Control_2
midazolam sedation
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 with superficial esophageal squamous cell carcinoma planned ESD.
Above 20 years old.
Adequate organ function.
No allergic episode with propofol and midazolam.
Written IC obtained from patients.
Key exclusion criteria
Severe disease in heart, lung, liver, or kidney.
Allergic episode with propofol or midazolam.
Women in pregnancy or breast-feeding
Any other reasosn by which docter judged inappropriate case.
Target sample size
132
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuaki Nagami |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
Asahimachi 1-4-3, Abeno-ku, Osaka-city, Japan
TEL
06-6645-3811
m1151493@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaki Ominami |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
Asahimachi 1-4-3, Abeno-ku, Osaka-city, Japan
TEL
06-6645-3811
Homepage URL
komesoudoh@yahoo.co.jp
Sponsor or person
Institute
Department of Gastroenterology, Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology, Osaka City University Graduate School of Medicine
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
大阪市立大学医学部附属病院 消化器内科
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 03 | 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
Completed
Date of protocol fixation
| 2014 | Year | 02 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 03 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 01 | Day |
Last modified on
| 2016 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015889
