UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017140 |
|---|---|
| Receipt number | R000018968 |
| Scientific Title | A multicenter exploratory study on the usefulness of covered metalic stent with fins(New GENOS) for biliary obstruction caused by unresectable middle-lower bile duct malignant tumors |
| Date of disclosure of the study information | 2015/04/14 |
| Last modified on | 2015/04/14 22:09:04 |
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Basic information
Public title
A multicenter exploratory study on the usefulness of covered metalic stent with fins(New GENOS) for biliary obstruction caused by unresectable middle-lower bile duct malignant tumors
Acronym
A multicenter exploratory study on the usefulness of New GENOS
Scientific Title
A multicenter exploratory study on the usefulness of covered metalic stent with fins(New GENOS) for biliary obstruction caused by unresectable middle-lower bile duct malignant tumors
Scientific Title:Acronym
A multicenter exploratory study on the usefulness of New GENOS
Region
| Japan |
Condition
Condition
Middle-lower bile duct obstruction caused by malignant tumors such as pancreas cancer, Ampullary carcinoma, bile duct cancer, gallbladder cancer, malignant lymphoma, lymph node metastasis, etc
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 fins(New GENOS)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
rate of stent migration
Key secondary outcomes
rate of recurrent biliary obstruction(RBO), time to recurrent biliary obstruction(TRBO)
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 New GENOS stent to non-resectable 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
non-resectable distal malignant
biliary obstruction
Written informed consent was obtained
from all patients before the procedures
Key exclusion criteria
difficult to approach by endoscope
Patients with ascites
Patients with hilar obstruction
World Health Organization performance status of 4
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Isayama |
Organization
Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
Division name
Department of Gastroenterology
Zip code
Address
7-3-1 Hongo Bunkyo-ku, Tokyo, Japan 113-8655
TEL
81-3-3815-5411
isayama-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunaga Ishigaki |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1 Hongo Bunkyo-ku, Tokyo, Japan 113-8655
TEL
81-3-3815-5411
Homepage URL
ISHIGAKIKA-INT@h.u-tokyo.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
no
Organization
Division
Category of Funding Organization
Other
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
| 2015 | Year | 04 | Month | 14 | 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
| 2014 | Year | 09 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | 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
| 2015 | Year | 04 | Month | 14 | Day |
Last modified on
| 2015 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018968
