UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033877 |
|---|---|
| Receipt number | R000038638 |
| Scientific Title | Safety and efficacy of non-anesthesiologist administrated propofol during endoscopic submucosal dissection of gastric epithelial tumors in patient with co-morbidity on American society of anaesthesiologists physical status classification |
| Date of disclosure of the study information | 2018/08/24 |
| Last modified on | 2018/08/23 23:34:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Safety and efficacy of non-anesthesiologist administrated propofol during endoscopic submucosal dissection of gastric epithelial tumors in patient with co-morbidity on American society of anaesthesiologists physical status classification
Acronym
A study on the safety and efficacy of propofol sedation
Scientific Title
Safety and efficacy of non-anesthesiologist administrated propofol during endoscopic submucosal dissection of gastric epithelial tumors in patient with co-morbidity on American society of anaesthesiologists physical status classification
Scientific Title:Acronym
A study on the safety and efficacy of propofol sedation
Region
| Japan |
Condition
Condition
Gastric epithelial tumors
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the safety of propofol during endoscopic submucosal dissection of gastric epithelial tumors in patient with co-morbidity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the safety of sedation by non-anesthesiologist administrated propofol in patient with comorbidity during ESD
Key secondary outcomes
Adverse events related to ESD, Clinicopathological tumor characteristics, and Hospital stay
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
All cases due to undergo gastric ESD was included in this study.
Key exclusion criteria
patient with allergy to soybeans
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiichiro Abe |
Organization
Dokkyo medical University
Division name
Department of Gastroenterology
Zip code
Address
880, Kitakobayashi, Mibu, Shimotsuga, Tochigi 321-0293, Japan
TEL
0282861111
abebe0319@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiichiro Abe |
Organization
Dokkyo medical University
Division name
Department of Gastroenterology
Zip code
Address
880, Kitakobayashi, Mibu, Shimotsuga, Tochigi 321-0293, Japan
TEL
0282861111
Homepage URL
abebe0319@gmail.com
Sponsor or person
Institute
Dokkyo medical University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JPN
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
| 2018 | Year | 08 | Month | 24 | 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
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2018 | Year | 08 | Month | 23 | Day |
Last modified on
| 2018 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038638
