UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033685 |
|---|---|
| Receipt number | R000038405 |
| Scientific Title | Endoscopic deployment of multiple self-expandable metal stents for unresectable malignant hilar biliary strictures: a combination of side-by-side and stent-in-stent methods. |
| Date of disclosure of the study information | 2018/08/08 |
| Last modified on | 2018/08/08 15:47:16 |
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Basic information
Public title
Endoscopic deployment of multiple self-expandable metal stents for unresectable malignant hilar biliary strictures: a combination of side-by-side and stent-in-stent methods.
Acronym
Multiple SEMSs deployment in hilar obstruction.
Scientific Title
Endoscopic deployment of multiple self-expandable metal stents for unresectable malignant hilar biliary strictures: a combination of side-by-side and stent-in-stent methods.
Scientific Title:Acronym
Multiple SEMSs deployment in hilar obstruction.
Region
| Japan |
Condition
Condition
malignant hilar biliary stricture
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of endoscopic deployment of multiple self-expandable metal stents for unresectable malingant hilar biliary strictures using a combination of side-by-side and stent-in-stent methods.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
technical and clinical success rates.
Key secondary outcomes
reinterventions, stent patency, and early and late adverse events.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
high-grade unresectable malignant hilar biliary stricture (Bismuth classification 3, 4)
Key exclusion criteria
resectable malignant hilar biliary stricture
Bismuth classification 1, 2
Performance Status 4
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuya koshitani |
Organization
Japan Community Healthcare Organization Kobe Central Hospital
Division name
Department of Gastroenterology
Zip code
Address
2-1-1 Soyamacho Kita-ku Kobe, 6511145 Japan.
TEL
078-578-2211
tkoshitani@aol.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya koshitani |
Organization
Japan Community Healthcare Organization Kobe Central Hospital
Division name
Department of Gastroenterology
Zip code
Address
2-1-1 Soyamacho Kita-ku Kobe, 6511145 Japan.
TEL
078-578-2211
Homepage URL
tkoshitani@aol.com
Sponsor or person
Institute
Japan Community Healthcare Organization Kobe Central Hospital
Institute
Department
Personal name
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
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
| 2018 | Year | 08 | Month | 08 | 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
| 2015 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2018 | Year | 08 | Month | 08 | Day |
Last modified on
| 2018 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038405
