UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011699 |
|---|---|
| Receipt number | R000013677 |
| Scientific Title | A side-by-side vs stent-in-stent method in multiple metallic stent placement for unresectable hilar biliary obstruction: A prospective multicenter randomized controlled trial |
| Date of disclosure of the study information | 2013/09/10 |
| Last modified on | 2023/03/22 15:27:15 |
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Basic information
Public title
A side-by-side vs stent-in-stent method in multiple metallic stent placement for unresectable hilar biliary obstruction: A prospective multicenter randomized controlled trial
Acronym
A side-by-side vs stent-in-stent method
Scientific Title
A side-by-side vs stent-in-stent method in multiple metallic stent placement for unresectable hilar biliary obstruction: A prospective multicenter randomized controlled trial
Scientific Title:Acronym
A side-by-side vs stent-in-stent method
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 compare the stent patency between side-by-side and stent-in-stent method for endoscopic multiple metallic stent placement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II,III
Assessment
Primary outcomes
Stent patency
Key secondary outcomes
Technical success rate
Complication rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Side-by-side method
Interventions/Control_2
Stent-in-stent method
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, Unresectable malignant hilar biliary obstruction with Bismuth classification II or higher advanced
2, Age>20years
3, Expected survival >30days
4, Informed consent was obtained
Key exclusion criteria
1, Post-gastrectomy
2, Inpossible to reach the papila.
3, Post hepatectomy
4, Post PTBD
5, Highly advanced biliary stricture
6, Severe acute cholangitis
7, Pregnant
8, Not included
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kawakami |
Organization
Hokkaido University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
Kita14 Nishi5, Kita-ku, Sapporo,Japan
TEL
0117161161
hiropon@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Midori Nishikawa |
Organization
Hokkaido University Hospital
Division name
Institutional Review Board
Zip code
Address
Kita14 Nishi5, Kita-ku, Sapporo,Japan
TEL
011-706-7636
Homepage URL
crjimu@huhp.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Graduate School of Medicine, Department of Gastroenterology and Hepatology
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 | 09 | Month | 10 | 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
Completed
Date of protocol fixation
| 2013 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2013 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 01 | 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
| 2013 | Year | 09 | Month | 10 | Day |
Last modified on
| 2023 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013677
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
