UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028894 |
|---|---|
| Receipt number | R000033067 |
| Scientific Title | Risk factors for strictures after esophageal ESD:a prospective single-arm observational study |
| Date of disclosure of the study information | 2017/08/30 |
| Last modified on | 2017/08/29 22:38:18 |
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Basic information
Public title
Risk factors for strictures after esophageal ESD:a prospective single-arm observational study
Acronym
Risk factors for strictures after esophageal ESD:a prospective single-arm observational study
Scientific Title
Risk factors for strictures after esophageal ESD:a prospective single-arm observational study
Scientific Title:Acronym
Risk factors for strictures after esophageal ESD:a prospective single-arm observational study
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the risk factors of strictures after esophageal ESD
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between ESD strictures and ESD ulcers factors
Key secondary outcomes
A frequency of balloon dilatation for ESD strictures
Restructure-free period
Adverse events
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
After esophageal endoscopic submucosal dissection
Intralesional steroid injection to prevent stricture after endoscopic submucosal dissection for esophageal cancer
No history of esophagectomy
Written informed consent
Key exclusion criteria
No infection
No possibility for pregnancy
No oral steroid intake or immunosuppressive agents
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryu Ishihara |
Organization
Osaka International Cancer Institute
Division name
Dept. of Gastrointestinal Oncology
Zip code
Address
3-1-69 Otemae Chuoku Osaka
TEL
+81-6-6945-1181
isihara-ry@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriko Matsuura |
Organization
Osaka International Cancer Institute
Division name
Dept. of Gastrointestinal Oncology
Zip code
Address
3-1-69 Otemae Chuoku Osaka
TEL
+81-6-6945-1181
Homepage URL
ibura9@yahoo.co.jp
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
| 2017 | Year | 08 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Preinitiation
Date of protocol fixation
| 2017 | Year | 07 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The aim of this observational study is to investigate the risk factors of ESD strictures after intralesional steroid injections.
Management information
Registered date
| 2017 | Year | 08 | Month | 29 | Day |
Last modified on
| 2017 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033067
