UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012318 |
|---|---|
| Receipt number | R000014404 |
| Scientific Title | Feasibility of single-step simultaneous side-by-side placement using 6Fr self-expandable metallic stent |
| Date of disclosure of the study information | 2013/11/16 |
| Last modified on | 2015/02/12 18:16:16 |
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Basic information
Public title
Feasibility of single-step simultaneous side-by-side placement using 6Fr self-expandable metallic stent
Acronym
Feasibility of single-step simultaneous side-by-side placement using 6Fr SEMS
Scientific Title
Feasibility of single-step simultaneous side-by-side placement using 6Fr self-expandable metallic stent
Scientific Title:Acronym
Feasibility of single-step simultaneous side-by-side placement using 6Fr SEMS
Region
| Japan |
Condition
Condition
Unresectable malignant hilar biliary obstruction
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate a safety and efficacy of single-step simultaneous side-by-side placemennt
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Technical success rate
Key secondary outcomes
Stent patency
Complication rate
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
Unresectable malignant hilar biliary obstruction
Bismuth II or more
Key exclusion criteria
Highly advanced biliary obstruction extending into bilateral 3rd intrahepatic biliary system and/or intrapancreatic bile duct
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kawakami |
Organization
Hokkaido University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
Kita15 Nishi7, Kita-ku, Sapporo
TEL
0117161161
hiropon@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazumichi Kawakubo |
Organization
Hokkaido University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
Kita15 Nishi7, Kita-ku, Sapporo
TEL
0117161161
Homepage URL
kkawakubo-gi@umin.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2013 | Year | 11 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2013 | Year | 11 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study
Management information
Registered date
| 2013 | Year | 11 | Month | 16 | Day |
Last modified on
| 2015 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014404
