UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001497 |
|---|---|
| Receipt number | R000001349 |
| Scientific Title | Midazolam v.s. propofol for sedaion in endoscopic submucosal dissection; a randomized phase II trial. KDOG0801 |
| Date of disclosure of the study information | 2008/11/11 |
| Last modified on | 2008/11/11 10:43:48 |
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Basic information
Public title
Midazolam v.s. propofol for sedaion in endoscopic submucosal dissection; a
randomized phase II trial. KDOG0801
Acronym
Sedation in endoscopic submucosal dissection
Scientific Title
Midazolam v.s. propofol for sedaion in endoscopic submucosal dissection; a
randomized phase II trial. KDOG0801
Scientific Title:Acronym
Sedation in endoscopic submucosal dissection
Region
| Japan |
Condition
Condition
early gastric cancer, gastric adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To estimate the efficacy and safety of the sedation with midazolam or propofol in endoscopic submucosal dissection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
the efficacy of sedation enough for endoscopic submucosal dissection.
Key secondary outcomes
the safety of sedation during endoscopic
submucosal dissection.
the sagety of sadation after endoscopic
submucosal dissection.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
sedation with propofol
Interventions/Control_2
sedation with midazolam
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 aerly gastric cancer or gastric adenoma planned ESD.
pathological diagnosis revealed group III,IV, or V.
above 20 years old.
ASA classification:I or II.
adequate organ function.
no allergic episode with midazolam and propofol.
written IC obtained from patients.
Key exclusion criteria
ASA classification:above III.
severe disease in heart, lung, liver, or
kidney.
allergic episode with midazolam or propofol.
women in pregnancy or breast-feeding
any other reasosn by which docter judged
inappropriate case.
Target sample size
138
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi TANABE |
Organization
Kitasato University East Hospital
Division name
Department of gastroenterology
Zip code
Address
Asamizodai2-1-1,Sagamihara, Kanagawa
TEL
042-748-9111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tohru SASAKI |
Organization
Kitasato University East Hospital
Division name
Department of gastroenterology
Zip code
Address
Asamizodai2-1-1, Sagamihra, Kanagawa
TEL
042-748-9111
Homepage URL
tohrus@t3.rim.or.jp
Sponsor or person
Institute
Kitasato Digestive disease and Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Kitasato University East hospital
Department of gastroenterology
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
| 2008 | Year | 11 | Month | 11 | 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
Date of protocol fixation
| 2008 | Year | 06 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 11 | Month | 11 | Day |
Last modified on
| 2008 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001349
