UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034054 |
|---|---|
| Receipt number | R000038223 |
| Scientific Title | Inside-stent placement for initial recurrent biliary obstruction after side-by-side self-expandable metal stenting in patients with unresectable malignant hilar biliary obstruction: a prospective exploratory trial |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2022/01/21 07:52:15 |
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Basic information
Public title
Inside-stent placement for initial recurrent biliary obstruction after side-by-side self-expandable metal stenting in patients with unresectable malignant hilar biliary obstruction: a prospective exploratory trial
Acronym
Inside-stent placement for initial recurrent biliary obstruction after side-by-side self-expandable metal stenting in patients with unresectable malignant hilar biliary obstruction
Scientific Title
Inside-stent placement for initial recurrent biliary obstruction after side-by-side self-expandable metal stenting in patients with unresectable malignant hilar biliary obstruction: a prospective exploratory trial
Scientific Title:Acronym
Inside-stent placement for initial recurrent biliary obstruction after side-by-side self-expandable metal stenting in patients with unresectable malignant hilar biliary obstruction
Region
| Japan |
Condition
Condition
Unresectable malignant hilar biliary obstrunction
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and sefety of re-intervention using inside stent for initial recurrent biliary obstruction after side-by-side self-expandable metal stenting in patients with unresectable malignant hilar biliary obstruction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to recurrent biliary obstruction
Key secondary outcomes
Technical success rate
Functional success rate
Procedure time
Non-obstruction rate
Adverse event
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Inside-stent placement for initial recurrent biliary obstruction after side-by-side self-expandable metal stenting
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
1. age =or >20
2. unresectable malignant hilar obstruction
3. initial recurrent biliary obstruction after side-by-side self-expandable metal stenting
4. providing written informed consent
Key exclusion criteria
1. liver abscess
2. ECOG Performance Status 4
3. prognosis less than 4 weeks
4. patients whose participation in the trial was judged to be inappropriate by the investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Kida |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
2520374
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa Japan
TEL
81-24-778-8111
m-kida@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Okuwaki |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
2520374
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa Japan
TEL
81-24-778-8111
Homepage URL
kokuwaki@kitasato-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
no organization
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
Institutional Ethics Committee of Kitasato University
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa Japan
Tel
81-42-778-8111
rinri@med.kitasato-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
Kitasato University Hospital
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 06 | Day |
Last modified on
| 2022 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038223
