UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003568 |
|---|---|
| Receipt number | R000004237 |
| Scientific Title | A Prospective Study of Covered Metallic Stent with Anti-Reflux Valve for unresectable malignant biliary obstruction |
| Date of disclosure of the study information | 2010/05/10 |
| Last modified on | 2014/07/17 12:59:13 |
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Basic information
Public title
A Prospective Study of Covered Metallic Stent with Anti-Reflux Valve for unresectable malignant biliary obstruction
Acronym
A Prospective Study of Covered Metallic Stent with Anti-Reflux Valve for unresectable malignant biliary obstruction
Scientific Title
A Prospective Study of Covered Metallic Stent with Anti-Reflux Valve for unresectable malignant biliary obstruction
Scientific Title:Acronym
A Prospective Study of Covered Metallic Stent with Anti-Reflux Valve for unresectable 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 evaluate the patency and safety of Covered Metallic Stent(CMS) with Anti-Reflux valve for CMS occulusion caused by reflux from duodenum or sludge, in patients with unresectable extrahepatic malignant biliary obstruction (for 15 eligible cases)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Stent patency period
Stent occulusion rate
Key secondary outcomes
Overall survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Anti-Reflux stent
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
Unresectable extrahepatic malignant biliary obstruction
Patients who were admitted by cholangitis caused by CMS occulusion due to duodeno-biliary reflux or sludge
Not limited by primary disease and male
more than 20 years old
Patients with written informed consent
Key exclusion criteria
Patients for whom endoscopic biliary drainage is impossible
Patients with hilar malignant biliary obstruction
Patients with performance status 4
Patients with severe impairment of other organ
Patients without written informed consent
Patients considered ineligible for this study
Patients with obstruction of distal side from third portion of duodenum
Patients with tumor invasion to the cystic duct
Patients with massive ascites
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Isayama |
Organization
Graduate School of Medicine and Faculty of Medicine, the university of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
isayama-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Isayama |
Organization
Graduate School of Medicine and Faculty of Medicine, the university of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
isayama-tky@umin.ac.jp
Sponsor or person
Institute
Graduate School of Medicine and Faculty of Medicine, the university of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Faculty of Medicine, University of Tokyo
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japanese RedCross Medical Center
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
東京大学医学部付属病院（東京都）、日本赤十字社医療センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | 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
| 2010 | Year | 02 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 05 | Day |
Last modified on
| 2014 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004237
