UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003259 |
|---|---|
| Receipt number | R000003938 |
| Scientific Title | Clinical effectiveness of prednisolone oral administration for esophageal stricture after endoscopic submucosal dissection for esophageal neoplasms. |
| Date of disclosure of the study information | 2010/02/26 |
| Last modified on | 2014/08/25 09:32:06 |
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Basic information
Public title
Clinical effectiveness of prednisolone oral administration for esophageal stricture after endoscopic submucosal dissection for esophageal neoplasms.
Acronym
Post-ESD esophageal strictures and prednisolone
Scientific Title
Clinical effectiveness of prednisolone oral administration for esophageal stricture after endoscopic submucosal dissection for esophageal neoplasms.
Scientific Title:Acronym
Post-ESD esophageal strictures and prednisolone
Region
| Japan |
Condition
Condition
esophageal neoplasms
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate usefulness of prednisolone oral administration for esophageal stricture after endoscopic submucosal dissection for esophageal neoplasms
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
endoscopic assessment of esophageal passage
symptoms
Key secondary outcomes
times of preventive endoscopic balloon dilatation
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
esopageal neoplasms that fuifil the ESD criteria with resection over 3/4 circumference
Key exclusion criteria
ESD failure
severe complications and adverse events
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hajime Isomoto |
Organization
Nagasaki University Hospital
Division name
Department of Endoscopy
Zip code
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7489
hajimei-ngs@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hajime Isomoto |
Organization
Nagasaki University Hospital
Division name
Department of Endoscopy
Zip code
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7489
Homepage URL
hajimei-ngs@umin.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University Hospital
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2010 | Year | 02 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
In 76 stenotic cases, median dilatation sessions and days were 0 for each (11/76, 14.5%).Wholly circumferentical ESD required 1.2 sessions on average.
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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 02 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
prevention of esophageal stricture and evaluation with upper endoscopy
the stricture-related symptoms
times of endoscopic balloon dilatation
Management information
Registered date
| 2010 | Year | 02 | Month | 25 | Day |
Last modified on
| 2014 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003938
