UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004724 |
|---|---|
| Receipt number | R000004455 |
| Scientific Title | Efficasy of steroid injection to artificial ulcer of endoscopic submucosal dissection and effect to regenerative mucosa |
| Date of disclosure of the study information | 2010/12/14 |
| Last modified on | 2012/06/14 15:09:01 |
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Basic information
Public title
Efficasy of steroid injection to artificial ulcer of endoscopic submucosal dissection and effect to regenerative mucosa
Acronym
Gastric steroid injection
Scientific Title
Efficasy of steroid injection to artificial ulcer of endoscopic submucosal dissection and effect to regenerative mucosa
Scientific Title:Acronym
Gastric steroid injection
Region
| Japan |
Condition
Condition
Early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Effectiveness of regeneration of artificial post ESD ulcer by local injection of steroid
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression of regenerative mucosa of post ESD ulcer and reduction of deformity of post ESD stomach
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Local injection to post ESD ulcer
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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients those who are undergone ESD
Key exclusion criteria
Patients those who have post ESD bleeding
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mori Hirohito |
Organization
Kagawa University
Division name
Department of gastroenterology and Neurology
Zip code
Address
1750-1 Miki Kida Kagawa Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kagawa university
Division name
Gastroenterology and Neurology
Zip code
Address
TEL
Homepage URL
hiro4884@med.kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa university
Department of gastroenterology and Neurology
Institute
Department
Personal name
Funding Source
Organization
Kagawa university
Department of gastroenterology and Neurology
Organization
Division
Category of Funding Organization
Other
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
香川大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2010 | Year | 06 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 14 | Day |
Last modified on
| 2012 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004455
