UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006327 |
|---|---|
| Receipt number | R000007494 |
| Scientific Title | A randomized clinical trial for the efficacy and safety of local steroid injection for prevention of post-ESD esophageal stenosis |
| Date of disclosure of the study information | 2011/09/15 |
| Last modified on | 2016/03/16 11:13:48 |
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Basic information
Public title
A randomized clinical trial for the efficacy and safety of local steroid injection for prevention of post-ESD esophageal stenosis
Acronym
A RCT of local steroid injection for prevention of post-ESD esophageal stenosis
Scientific Title
A randomized clinical trial for the efficacy and safety of local steroid injection for prevention of post-ESD esophageal stenosis
Scientific Title:Acronym
A RCT of local steroid injection for prevention of post-ESD esophageal stenosis
Region
| Japan |
Condition
Condition
Early esophageal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of local steroid injection for prevention of post-ESD esophageal stenosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The proportion of patients who need endoscopic dilatation for post-ESD esophageal stenosis
Key secondary outcomes
1. The frequency of the complication with local steroid injection
2. The frequency of the complication with endoscopic dilatation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Local steroid injection (Triamcinolone Acetonide) after ESD
Interventions/Control_2
No treatment after ESD
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
Patients with superficial squamous cell carcinoma whose mucosal defect after ESD is expected to be over three-fourths of the whole circumference (being highly associated with post ESD stenosis)
Key exclusion criteria
Excluded if patients have:
1. previous therapy experience
2. steroid treatment for other diseases
3. esophageal adenocarcinoma
4. swallowing difficulty
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Takahashi |
Organization
Keiyukai Sapporo Hospital
Division name
Dept. of Gastroenterology
Zip code
Address
1-1, Hondori 14 north, Shiroishi-ku, Sapporo, Hokkaido, Japan
TEL
011-863-2101
hiroaki@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Takahashi |
Organization
Keiyukai Sapporo Hospital
Division name
Dept. of Gastroenterology
Zip code
Address
1-1, Hondori 14 north, Shiroishi-ku, Sapporo, Hokkaido, Japan
TEL
011-863-2101
Homepage URL
hiroaki@sapmed.ac.jp
Sponsor or person
Institute
Dept. of Gastroenterology, Keiyukai Sapporo Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
恵佑会札幌病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/25609176
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 | 01 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 12 | Day |
Last modified on
| 2016 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007494
