UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000738 |
|---|---|
| Receipt number | R000000886 |
| Scientific Title | A prospective single blind randomized controlled trial of covered versus uncovered biliary metal stents for the management of distal malignant biliary obstruction. |
| Date of disclosure of the study information | 2007/06/11 |
| Last modified on | 2009/12/25 19:27:54 |
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Basic information
Public title
A prospective single blind randomized controlled trial of covered versus uncovered biliary metal stents for the management of distal malignant biliary obstruction.
Acronym
A randomized controlled trial of covered versus uncovered biliary metal stents for the management of distal malignant biliary obstruction.
Scientific Title
A prospective single blind randomized controlled trial of covered versus uncovered biliary metal stents for the management of distal malignant biliary obstruction.
Scientific Title:Acronym
A randomized controlled trial of covered versus uncovered biliary metal stents for the management of distal malignant biliary obstruction.
Region
| Japan |
Condition
Condition
Distal malignant biliary obstraction
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare the patency between covered metallic stents and uncovered metallic stents for the patients of distal malignant biliary obstruction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Comparison of the duration of the stents patency
Key secondary outcomes
comparison of the safty
comparison of the cost
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
Insertion of covered self expandable metal stents
Interventions/Control_2
Insertion of uncovered self expandable metal stents
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, Patinets who are admitted in the International Medical Center of Japan (IMCJ).
2, Obstraction of the distal bile duct without hilar lesions because of tumor invasion or compression of metastatic lymph nodes.
3, The tumors are unresectable because of tumor progression and/or patient's complications.
4, Performance status (PS) are 0 to 3.
Key exclusion criteria
1, Patients with severe dysfunction of liver, kidney, heart, or lung.
2, Patients who are estimated to die within two months.
3,Patients with history of insertion of biliay metal stents
4, Patients with history of surgery of the common bile ducts.
5, Patients with stenosis of the hepatic ducts or the intra hepatic bile ducts.
6, Patients with stenosis of the duodenum which prevent passage of foods.
Target sample size
112
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masao Kobayakawa |
Organization
International Medical Center of Japan
Division name
Department of gastroenterology
Zip code
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
International Medical Center of Japan
Division name
Department of gastroenterology
Zip code
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
TEL
Homepage URL
mkobaya@imcj.hosp.go.jp
Sponsor or person
Institute
International Medical Center of Japan
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
| 2007 | Year | 06 | Month | 11 | 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
| 2007 | Year | 06 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 09 | 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
| 2007 | Year | 06 | Month | 08 | Day |
Last modified on
| 2009 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000886
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