UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024561 |
|---|---|
| Receipt number | R000028165 |
| Scientific Title | Efficacy and safety of sedative agents for endoscopic submucosal dissection of esophageal carcinoma |
| Date of disclosure of the study information | 2016/10/25 |
| Last modified on | 2022/05/02 20:22:38 |
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Basic information
Public title
Efficacy and safety of sedative agents for endoscopic submucosal dissection of esophageal carcinoma
Acronym
Efficacy and safety of sedative agents for endoscopic submucosal dissection of esophageal carcinoma
Scientific Title
Efficacy and safety of sedative agents for endoscopic submucosal dissection of esophageal carcinoma
Scientific Title:Acronym
Efficacy and safety of sedative agents for endoscopic submucosal dissection of esophageal carcinoma
Region
| Japan |
Condition
Condition
esophageal carcinoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To reveal efficacy and safety of propofol and midazolam in ESD for early esophageal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
treatment performance for endoscopic submucosal dissection using midazolam or propofol
Key secondary outcomes
Base
Study type
Observational
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
The patients who have a superficial esophageal cancer treated by endoscopic resection or esophagectomy
Key exclusion criteria
Patients whom a researcher judged to be inappropriate as a subject.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Naito |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Molecular Gastroenterology and Hepatology
Zip code
602-8566
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5519
ynaito@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Dohi |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Molecular Gastroenterology and Hepatology
Zip code
602-8566
Address
465 Kawaramachi Hirokoji Kamigyo-ku, Kyoto
TEL
075-251-5519
Homepage URL
osamu-d@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University 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
Kyoto Prefectural University of Medicine
Address
465 Kajiicho Hirokoji Kawaramachi Kamigyo-ku, Kyoto, Japan
Tel
0752515337
rinri@koto.kpu-m.ac.jp
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
| 2016 | Year | 10 | Month | 25 | 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
| 2016 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Clinical information was reviewed retrospectively.
Management information
Registered date
| 2016 | Year | 10 | Month | 25 | Day |
Last modified on
| 2022 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028165
