UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008587 |
|---|---|
| Receipt number | R000010088 |
| Scientific Title | A multicenter, prospective, randomised study of "covered" versus "uncovered" stents for the management of distal malignant biliary obstruction |
| Date of disclosure of the study information | 2012/09/01 |
| Last modified on | 2017/11/23 23:49:50 |
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Basic information
Public title
A multicenter, prospective, randomised study of "covered" versus "uncovered" stents for the management of distal malignant biliary obstruction
Acronym
A multicenter randomized controlled trial of metallic stent for unresectable distal malignant biliary obstruction
Scientific Title
A multicenter, prospective, randomised study of "covered" versus "uncovered" stents for the management of distal malignant biliary obstruction
Scientific Title:Acronym
A multicenter randomized controlled trial of metallic stent for unresectable distal malignant biliary obstruction
Region
| Japan |
Condition
Condition
Malignant biliary obstruction
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the patency and safety of Fully-covered versus Uncovered WallFlex stent for unresectable distal malignant biliary obstruction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Time to stent dysfunction
Key secondary outcomes
Effectiveness
1) Stent patency period
2) Survival period
3) Event free survival
4) Stent patency period after reintervention
5) Time to stent dysfunction after reintervention
6) Cost effectiveness
Safety
1) Early complications
2) Late complications
3) Technical success rate
4) Removability of the stent
5) Removability of the second stent
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
WallFlex Fully-covered biliary stent
Interventions/Control_2
WallFlex Uncovered biliary stent
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) Patients with unresectable distal malignant biliary obstruction, not limited to primary disease.
2) Patients with predictable prognosis of more than 4 months.
3) Patients with written informed consent.
4) Patients with performance status 0-3.
Key exclusion criteria
1) Patients with massive ascites.
2) Patients with severely impaired organ function.
3) Patients for whom endoscopic biliary drainage is difficult.
4) Patients with duodenal obstruction.
5) Patients whose antithrombotic drugs cannot be stopped.
6) Patients considered ineligible for this study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Chiba |
Organization
Faculty of Medicine, Kyoto University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-4319
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Kurita |
Organization
Faculty of Medicine, Kyoto University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-4319
Homepage URL
akurita@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Faculty of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Faculty of Medicine, Kyoto University
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
| 2012 | Year | 09 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 01 | Day |
Last modified on
| 2017 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010088
| 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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