UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004405 |
|---|---|
| Receipt number | R000005131 |
| Scientific Title | The efficacy and safety of inner coated ComVi stent for management of distal malignant biliary obstruction |
| Date of disclosure of the study information | 2010/10/25 |
| Last modified on | 2013/01/09 18:36:22 |
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Basic information
Public title
The efficacy and safety of inner coated ComVi stent for management of distal malignant biliary obstruction
Acronym
Inner coated ComVi stent for distal malignant biliary obstruction
Scientific Title
The efficacy and safety of inner coated ComVi stent for management of distal malignant biliary obstruction
Scientific Title:Acronym
Inner coated ComVi stent for distal malignant biliary obstruction
Region
| Japan |
Condition
Condition
Cases of distal malignant biliary obstruction
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The evaluation of the safety and efficacy of a newly designed metallic stent (inner ComVi stent)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Patency of Inner coated ComVi stent
Key secondary outcomes
Compliation
Median survival period of cases
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
Placement of inner coated ComVi stent for the cases of distal malignant biliary obstruction
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)The Case of distal malignant biliary obstruction
2)The level of total bilirubin is more than 3mg/dl.
3)The expected life expectancy for the patients is more than two months.
4)Written informed consent is obtained.
5)Activity of the case is considered as 0 to 2 by ECOG performance status score.
Key exclusion criteria
1) Ascites
2) Severe coexisting illness
3) Inaccessible to duodenal papilla due to post surgical status
4) Difficult cannulation to duodenal papilla
5) Intestinal or colonic obstruction
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Isayama |
Organization
The University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1 Hongo Bunkyo-ku Tokyo Japan
TEL
03-3815-5411ext.33070
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Natsuyo Yamamoto |
Organization
The University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1 Hongo Bunkyo-ku Tokyo Japan
TEL
03-3815-5411ext.33070
Homepage URL
natsuyo@tke.att.ne.jp
Sponsor or person
Institute
The University of Tokyo,Department of Gastroenterology
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
東京大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 25 | 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 | 10 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2012 | Year | 11 | Month | 25 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 18 | Day |
Last modified on
| 2013 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005131
