UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044572 |
|---|---|
| Receipt number | R000050914 |
| Scientific Title | A prospective clinical trial to clarify the usefulness of re-intervention after placement of multiple metal stents using a device for inducing a stent delivery system with a function for expansion. |
| Date of disclosure of the study information | 2021/06/25 |
| Last modified on | 2021/12/09 09:34:34 |
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Basic information
Public title
A prospective clinical trial to clarify the usefulness of re-intervention after placement of multiple metal stents using a device for inducing a stent delivery system with a function for expansion.
Acronym
A prospective clinical trial to clarify the usefulness of re-intervention after placement of multiple metal stents using a device for inducing a stent delivery system with a function for expansion.
Scientific Title
A prospective clinical trial to clarify the usefulness of re-intervention after placement of multiple metal stents using a device for inducing a stent delivery system with a function for expansion.
Scientific Title:Acronym
A prospective clinical trial to clarify the usefulness of re-intervention after placement of multiple metal stents using a device for inducing a stent delivery system with a function for expansion.
Region
| Japan |
Condition
Condition
Obstructive jaundice
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
When the metal stent is occluded, it is necessary to perform the stent placement endoscopically again, but it is often difficult to re-place the stent. Against this background, a stent delivery system induction device with extended function has become available in Japan, and the purpose is to prospectively examine cases in which retreatment was performed after stent occlusion and clarify the results.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary endpoint: Success rate of procedure
The success rate of the procedure in this study is based on the case where stent placement can be finally performed using EndoSheather.
Key secondary outcomes
Secondary endpoints: clinical response rate, type and frequency of complications
The clinical effect should be improved by T-bil <1.3 mg / dL or 50% or more of preoperative T-Bil. Early complications are complications that occur within 30 days, and late complications are complications that occur after that.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Period from the date of permission to conduct research to April 30, 2023
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
20 years old and over
Obstructive jaundice case
Key exclusion criteria
Cases where there was an offer to refuse participation
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | miyano |
| Middle name | |
| Last name | akira |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Gastroenterology
Zip code
569-8686
Address
2-7 Daigaku-machi, Takatsuki, Osaka, JAPAN
TEL
072-683-1221
akira.miyano@opmu.ac.jp
Public contact
Name of contact person
| 1st name | miyano |
| Middle name | |
| Last name | akira |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Gastroenterology
Zip code
569-8686
Address
2-7 Daigaku-machi, Takatsuki, Osaka, JAPAN
TEL
072-683-1221
Homepage URL
akira.miyano@opmu.ac.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical and Pharmaceutical University
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
Osaka Medical and Pharmaceutical University
Address
2-7 Daigaku-machi, Takatsuki, Osaka, JAPAN
Tel
072-683-1221
akira.miyano@opmu.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
| 2021 | Year | 06 | Month | 25 | 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
| 2021 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 17 | Day |
Last modified on
| 2021 | 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=R000050914
| 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 |
