UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016178 |
|---|---|
| Receipt number | R000003937 |
| Scientific Title | Clinical effectiveness of prednisolone oral administration for esophageal stricture after endoscopic submucosal dissection. |
| Date of disclosure of the study information | 2015/01/11 |
| Last modified on | 2015/01/11 22:07:11 |
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Basic information
Public title
Clinical effectiveness of prednisolone oral administration for esophageal stricture after endoscopic submucosal dissection.
Acronym
Post-ESD esophageal strictures and prednisolone
Scientific Title
Clinical effectiveness of prednisolone oral administration for esophageal stricture after endoscopic submucosal dissection.
Scientific Title:Acronym
Post-ESD esophageal strictures and prednisolone
Region
| Japan |
Condition
Condition
esophageal neoplasm
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Effectiveness of prednisolone oral administration for esophageal strictures after endoscopic submucosal dissection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
prevention of esophageal stricture
presence of the stricture-related symptoms
Key secondary outcomes
times of preventive endoscopic balloon dilatation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
oral prednisolone
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
inidication for ESD
no related complications
Key exclusion criteria
presence of related complications
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hajime Isomoto |
Organization
Nagasaki University Hospital
Division name
Endoscopy
Zip code
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7336
hajimei2002@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hajime Isomoto |
Organization
Nagasaki University Hospital
Division name
Endoscopy
Zip code
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7336
Homepage URL
hajimei2002@yahoo.co.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagasaki 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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 11 | 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 | 02 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 26 | 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
| 2015 | Year | 01 | Month | 11 | Day |
Last modified on
| 2015 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003937
