UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010707 |
|---|---|
| Receipt number | R000012515 |
| Scientific Title | Efficacy and safety of propofol sedation during therapeutic endoscopy |
| Date of disclosure of the study information | 2013/05/13 |
| Last modified on | 2019/10/09 11:39:38 |
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Basic information
Public title
Efficacy and safety of propofol sedation during therapeutic endoscopy
Acronym
propofol sedation during therapeutic endoscopy
Scientific Title
Efficacy and safety of propofol sedation during therapeutic endoscopy
Scientific Title:Acronym
propofol sedation during therapeutic endoscopy
Region
| Japan |
Condition
Condition
early gastric cancer, pancreato-biliary disease, esophago-gastric varices
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and safty of propofol sedation during therapeutic endoscopy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
treatment outocome
Key secondary outcomes
complication
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
propofol sedation
Interventions/Control_2
therapeutic endoscopy
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
1,Patients will receive therapeutic endoscopy (ESD, ERCP, EIS).
2, ECOG-Performanece: 0 or 1
3, over 20 years old
4, nomal liver and renal function
Key exclusion criteria
1, liver and renal dysfunction
2, Patients disagree with propofol sedatoon
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsutoshi Obara |
Organization
Fukushima Medical University Hospital
Division name
Department of Endoscopy
Zip code
Address
1 Hikarigaoka, Fukushima, Japan
TEL
024-547-1583
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Fukushima Medical University Hospital
Division name
Department of Endoscopy
Zip code
Address
TEL
024-547-1583
Homepage URL
takuto@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University Hospital
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
福島県立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 13 | 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
| 2013 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 07 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 13 | Day |
Last modified on
| 2019 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012515
