UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005649 |
|---|---|
| Receipt number | R000006676 |
| Scientific Title | The evaluation of prophylactic effect of intralesional steroid injection to prevent esophageal stricture after ESD(endoscopic submucosal dissection) of superficial esophageal cancers |
| Date of disclosure of the study information | 2011/05/27 |
| Last modified on | 2016/12/09 10:51:19 |
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Basic information
Public title
The evaluation of prophylactic effect of intralesional steroid injection to prevent esophageal stricture after ESD(endoscopic submucosal dissection) of superficial esophageal cancers
Acronym
The evaluation of prophylactic effect of intralesional steroid injection to prevent esophageal stricture after ESD(endoscopic submucosal dissection) of superficial esophageal cancers
Scientific Title
The evaluation of prophylactic effect of intralesional steroid injection to prevent esophageal stricture after ESD(endoscopic submucosal dissection) of superficial esophageal cancers
Scientific Title:Acronym
The evaluation of prophylactic effect of intralesional steroid injection to prevent esophageal stricture after ESD(endoscopic submucosal dissection) of superficial esophageal cancers
Region
| Japan |
Condition
Condition
superficial esophageal cancers
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the prophylactic effect of intralesional steroid injection to prevent esophageal stricture after ESD of superficial esophageal cancers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
To compare the treatment duration between 2 groups (the weekly group receive 40mg of triamcinolone acetonide weekly, the biweekly group receive 40mg of triamcinolone acetonide biweekly )
Key secondary outcomes
Frequency of EBD(endoscopic balloon dilations), Stricture rate, Frequency of adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The weekly group receive 40mg of triamcinolone acetonide weekly
Interventions/Control_2
The biweekly group receive 40mg of triamcinolone acetonide biweekly
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Relative adaptational lesion for ESD and more than 3/4 luminal circumferencial mucosal defect
Key exclusion criteria
1)Not acceptance to participate in the study
2)Allergy for triamcinolone acetonide
3)Severe DM or adrenal malfunction
4)Inappropriate for this trial
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Morita Yoshinori |
Organization
Kobe University, School fo Medicine
Division name
Department of Gastroenterology
Zip code
Address
7-5-1,kusunoki-cho,cho-ku,Kobe 650-0017 Japan.
TEL
0783826305
ymorita@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Morita Yoshinori |
Organization
Kobe University, School fo Medicine
Division name
Department of Gastroenterology
Zip code
Address
7-5-1,kusunoki-cho,cho-ku,Kobe 650-0017 Japan.
TEL
0783826305
Homepage URL
ymorita@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University, School fo Medicine
Institute
Department
Personal name
Funding Source
Organization
Kobe University, School fo 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
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
| 2011 | Year | 05 | Month | 27 | 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 | 08 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2012 | Year | 01 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 26 | Day |
Last modified on
| 2016 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006676
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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