UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050948 |
|---|---|
| Receipt number | R000058069 |
| Scientific Title | radial incision and balloon dilation for esophageal benign stenosis |
| Date of disclosure of the study information | 2023/05/01 |
| Last modified on | 2023/04/28 07:06:39 |
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Basic information
Public title
radial incision and balloon dilation for esophageal benign stenosis
Acronym
radial incision and balloon dilation for esophageal benign stenosis
Scientific Title
radial incision and balloon dilation for esophageal benign stenosis
Scientific Title:Acronym
radial incision and balloon dilation for esophageal benign stenosis
Region
| Japan |
Condition
Condition
esophageal benign stenosis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
retrospective analysis of efficacy and safety of endoscopic balloon dilation with mucosal incision for esophageal benign stenosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
incidence of re-stenosis after procedure
Key secondary outcomes
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
esophageal benign stenosis
Key exclusion criteria
cases without following up after procedure
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Shibagaki |
Organization
Shimane University Hospital
Division name
Endoscopy
Zip code
693-8501
Address
89-1 Enya Izumo Japan
TEL
0853-20-2190
kotaro@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Maki |
| Middle name | |
| Last name | Watanabe |
Organization
Shimane University Hospital
Division name
Gastroenterology
Zip code
693-8501
Address
89-1 Enya Izumo Japan
TEL
0853202190
Homepage URL
maki-w@med.shimane-u.ac.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Kotaro Shibagaki
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
same above
Address
same above
Tel
0853202190
kotaro@med.shimane-u.ac.jp
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
| 2023 | Year | 05 | Month | 01 | 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
| 2022 | Year | 03 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective observative study.
We will analyze the improvement of stenosis symptom, recurrence rate of stenosis, and adverse events after RI-BD for esophageal benign stenosis.
Management information
Registered date
| 2023 | Year | 04 | Month | 28 | Day |
Last modified on
| 2023 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058069
