UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037323 |
|---|---|
| Receipt number | R000041971 |
| Scientific Title | Multicenter prospective study |
| Date of disclosure of the study information | 2019/07/11 |
| Last modified on | 2019/07/10 11:47:09 |
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Basic information
Public title
Multicenter prospective study of stent-in-stent deployment using novel uncovered stent for malignant hilar obstruction
Acronym
Multicenter prospective study of stent-in-stent deployment using novel uncovered stent for malignant hilar obstruction
Scientific Title
Multicenter prospective study
Scientific Title:Acronym
Multicenter prospective study
Region
| Japan |
Condition
Condition
Malignant hepatic hilar obstruction
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate technical feasibility of stent deployment without any dilation using HIRZO stent
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Technical feasibility
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
HIRZO stent
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
Over 20 years
Malignant hepatic hilar obstruction with histological evidence
Bismuth classification II, III, IV
ECOG(Eastern Cooperative Oncology Group) performance status 0-3
Informed content
Key exclusion criteria
Inaccessible papilla
Over ASA3
Over ECOG 4
Poor prognosis (3 months)
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Ogura |
Organization
Osaka Medical College
Division name
2nd Department of Internal Medicine
Zip code
5698686
Address
2-7 Daigakumachi Takatsukishi
TEL
072-683-1221
oguratakeshi0411@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Ogura |
Organization
Osaka Medical College
Division name
2nd Department of Internal Medicine
Zip code
5698686
Address
2-7 Daigakumachi Takatsukishi
TEL
072-683-1221
Homepage URL
oguratakeshi0411@yahoo.co.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
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
Osaka Medical College
Address
2-7 Daigakumachi Takatsukishi
Tel
072-683-1221
rinri@osaka-med.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
| 2019 | Year | 07 | Month | 11 | 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
| 2019 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 10 | Day |
Last modified on
| 2019 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041971
| 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 |
