UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029869 |
|---|---|
| Receipt number | R000034114 |
| Scientific Title | The Safety and Efficacy of Esophageal Thin Metallic Stent for Stricture after Radiotherapy |
| Date of disclosure of the study information | 2017/11/09 |
| Last modified on | 2018/11/21 18:31:32 |
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Basic information
Public title
The Safety and Efficacy of Esophageal Thin Metallic Stent for Stricture after Radiotherapy
Acronym
Ethics trial
Scientific Title
The Safety and Efficacy of Esophageal Thin Metallic Stent for Stricture after Radiotherapy
Scientific Title:Acronym
Ethics trial
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of esophageal thin metallic stent for stricture after radiotherapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence rate of esophageal hemorrhage, esophageal perforation, and mediastinal infection which CTCAE grade is not less than 3
Key secondary outcomes
Occurrence rate and the types of adverse events
Patient-reported best dysphagia score after stent placement
Time periods while patient-reported dysphagia score is no more than 2
Survival time after stent placement
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
1) Cases of esophageal thin metallic stent placement for stricture after radiotherapy
2) Patients with informed consent
Key exclusion criteria
1) Patient is judged to be inappropriate for enrollment of the study for any reason by the investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noboru Kawata |
Organization
Shizuoka Cancer Center
Division name
Division of Endoscopy
Zip code
Address
1007 Shimonagakubo, Nagaizumi, Suntogun, Shizuoka, Japan
TEL
055-989-5222
n.kawata@scchr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuyuki Murai |
Organization
Shizuoka Cancer Center
Division name
Division of Endoscopy
Zip code
Address
1007 Shimonagakubo, Nagaizumi, Suntogun, Shizuoka, Japan
TEL
055-989-5222
Homepage URL
k.murai@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Shizuoka Cancer Center
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 | 11 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 10 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Enrollment: Twenty
Term of registration: Two years
Term of follow-up: Until the last survivor die or a half year after stent placement for the last survivor
Study duration: Two and a half years
Management information
Registered date
| 2017 | Year | 11 | Month | 07 | Day |
Last modified on
| 2018 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034114
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
