UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026951 |
|---|---|
| Receipt number | R000029885 |
| Scientific Title | Evaluation of a novel tornado-shape basket catheter for removing bile duct stones: a multicenter clinical feasibility study |
| Date of disclosure of the study information | 2017/05/01 |
| Last modified on | 2018/04/12 11:33:48 |
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Basic information
Public title
Evaluation of a novel tornado-shape basket catheter for removing bile duct stones: a multicenter clinical feasibility study
Acronym
Evaluation of a novel tornado-shape basket
Scientific Title
Evaluation of a novel tornado-shape basket catheter for removing bile duct stones: a multicenter clinical feasibility study
Scientific Title:Acronym
Evaluation of a novel tornado-shape basket
Region
| Japan |
Condition
Condition
bile duct stone
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clibical feasibilityof a novel tornado-shape basket catheter for removing bile duct stones
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
complete stone clearance rate at single endocopic session
Key secondary outcomes
adverse events related to the procedure and their occurrence rates
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
endoscopic removal of bile duct stones using a novel baslet catheter (FG-V451P, Olympus, Tokyo, Japan)
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) minimum diameter of the largest bile duct stone measured at ERCP 11 mm or smaller,
with no limitation in the number of stones
2) after written informed consent
3) good ADL (ECOG performence status 0-2)
Key exclusion criteria
1) previous gastrectomy,except for Billroth-I reconstruction
2) biliary stenosis
3) recurrent stone in patients with previous ES(widely opened biliary orifice)
4) age younger than 20 years
5) bleeding tendency
a) platelet count less than 50,000/mm3, b) international normalized ratio (INR)[1.5]
c) patients receiving anticoagulants
d) patients with underlying diseases associated with bleeding tendency and coagulopathy
6) unable or not wishing to give informed consent
7) judged by a physician to be inappropriate for inclusion in the study for any other reason
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro Yasuda |
Organization
Teikyo University Mizonokuchi Hospital
Division name
Dept. of Gastroenterology
Zip code
Address
3-8-3 Mizonokuchi, Takatsu-ku, Kawasaki 213-8507, Kanagawa, Japan
TEL
044-844-3333
yasudaich@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ichiro Yasuda |
Organization
Teikyo University Mizonokuchi Hospital
Division name
Dept. of Gastroenterology
Zip code
Address
3-8-3 Mizonokuchi, Takatsu-ku, Kawasaki 213-8507, Kanagawa, Japan
TEL
044-844-3333
Homepage URL
yasudaich@gmail.com
Sponsor or person
Institute
Teikyo University Mizonokuchi Hospital, Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Teikyo University Mizonokuchi Hospital, Department of Gastroenterology
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
帝京大学医学部附属溝口病院、手稲渓仁会病院、福島県立医科大学会津医療センター、埼玉医科大学国際医療センター、順天堂大学順天堂医院、東京医科大学病院、岐阜市民病院、君津中央病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2017 | Year | 02 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | 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
| 2017 | Year | 04 | Month | 11 | Day |
Last modified on
| 2018 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029885
| 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 |
