UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009008 |
|---|---|
| Receipt number | R000010566 |
| Scientific Title | Feasibility and efficacy of new lumenal-apposition metal stent (AXIOS stent) for unresectable malignant distal biliary obstruction |
| Date of disclosure of the study information | 2012/09/29 |
| Last modified on | 2013/04/30 13:57:23 |
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Basic information
Public title
Feasibility and efficacy of new lumenal-apposition metal stent (AXIOS stent) for unresectable malignant distal biliary obstruction
Acronym
Biliary AXIOS study
Scientific Title
Feasibility and efficacy of new lumenal-apposition metal stent (AXIOS stent) for unresectable malignant distal biliary obstruction
Scientific Title:Acronym
Biliary AXIOS study
Region
| Japan |
Condition
Condition
unresectable malignant distal biliary obstruction
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate a novel lumen-apposing stent designed for transenteric drainage of bile duct.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Successful insertion rate
Key secondary outcomes
Kinds and frequency of complications
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
| Maneuver |
Interventions/Control_1
Endoscopic ultrasonography-guided biliary drainage
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients in whom biliary drainage is required. Unresectable malignant distal biliary obstruction.
2) Patients consent to be included in the study based on his/her own free will after sufficient informing and understanding of the study.
Key exclusion criteria
1) Cases having difficulty in endoscopic approach
2) Cases in Perfomance status 4
3) Cases with sever complication in other organs
4) Cases without informed consent
5) Cases judged by principal investigator to be inadequate as subjects
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takao Itoi |
Organization
Tokyo Medical University Hospital
Division name
Department of the 4th Internal medicine (Gastroenterology and Hepatology)
Zip code
Address
6-7-1 Nishishijuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokyo Medical University Hospital
Division name
Department of the 4th Internal medicine (Gastroenterology and Hepatology)
Zip code
Address
6-7-1 Nishishijuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
Homepage URL
itoi@tokyo-med.ac.jp
Sponsor or person
Institute
Department of the 4th Internal medicine
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
東京医科大学病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | Month | 29 | 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
| 2012 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 29 | Day |
Last modified on
| 2013 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010566
