UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032245 |
|---|---|
| Receipt number | R000036712 |
| Scientific Title | The measurement of the distance between desired position and released position when releasing the self-expandable metallic stent to bile duct. |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2018/10/15 13:10:45 |
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Basic information
Public title
The measurement of the distance between desired position and released position when releasing the self-expandable metallic stent to bile duct.
Acronym
The measurement of the distance between desired position and released position when releasing the self-expandable metallic stent to bile duct.
Scientific Title
The measurement of the distance between desired position and released position when releasing the self-expandable metallic stent to bile duct.
Scientific Title:Acronym
The measurement of the distance between desired position and released position when releasing the self-expandable metallic stent to bile duct.
Region
| Japan |
Condition
Condition
distal malignant biliary obstruction
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To measure of the distance between desired position and released position when releasing the self-expandable metallic stent to bile duct.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of accuracy of stent released to the bile duct
(distance between desired position and released position)
Key secondary outcomes
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
Limit of biliary 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
1.over 20 years old
2.Diagnosed as malignant disease
3.Case of obstructive jaundice due to distal biliary obstruction
4.Consent has been obtained
5.Surgery was impossible or did not want surgery
Key exclusion criteria
1.Cases where consent is not obtained
2.Serious mental illness
3.Cases with reconstructed intestinal tract
4.Cases with metal allergy
5.Cases judged to be unsuitable for metal stent placement
6.Cases judged inappropriate for other reasons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kida Mitsuhiro |
Organization
Kitasato University
Division name
gastroenterology
Zip code
Address
Kitasato,Minami ku,Sagamihara shi,Kanagawa,Japan
TEL
042-778-8111
m-kida@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hasegawa Rikiya |
Organization
Kitasato University
Division name
gastroenterology
Zip code
Address
Kitasato,Minami-ku,Sagamihara-shi,Kanagawa,Japan
TEL
042-778-8111
Homepage URL
k-r.h@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Kitasato University
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
| 2018 | Year | 05 | Month | 01 | 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
| 2018 | Year | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | 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
| 2018 | Year | 04 | Month | 14 | Day |
Last modified on
| 2018 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036712
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
