UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011887 |
|---|---|
| Receipt number | R000013554 |
| Scientific Title | Basket versus Balloon catheter for Endoscopic Extraction of Bile duct stones: A prospective, Multicenter study. |
| Date of disclosure of the study information | 2013/09/30 |
| Last modified on | 2015/11/01 15:16:32 |
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Basic information
Public title
Basket versus Balloon catheter for Endoscopic Extraction of Bile duct stones: A prospective, Multicenter study.
Acronym
BD stone study in Hokkaido
Scientific Title
Basket versus Balloon catheter for Endoscopic Extraction of Bile duct stones: A prospective, Multicenter study.
Scientific Title:Acronym
BD stone study in Hokkaido
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 compare the rate of the complete stone extraction between the balloon catheter and the basket catheter
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the rate of the complete stone extraction
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Basket catheter
Interventions/Control_2
Balloon catheter
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) Bile duct stone 10mm or less in diameter
and
2) bile duct 15mm or less in diameter
Key exclusion criteria
1) no filling defect on ERC
2) the patients with altered anatomy after surgery
(excepts for B-1 reconstruction)
3)the patients with biliary stricture.
4)the patients with acute pancreatitis.
5)the patients with severe acute cholangitis
6)the patients with hemorrhagic diathesis
7)the patients with severe cardiovascular or pulmonary disorder
8)the patients with Performance status 4
9)Woman suspected of being pregnant.
9)Patients who are judged inappropriate by medical examiner.
Target sample size
170
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotoshi Ishiwatari |
Organization
Sapporo Medical University
Division name
4th department of Internal Medicine
Zip code
Address
Minami 1-jo, Nishi 16-chome, Chuoku, Sapporo, Hokkaido
TEL
011-611-2111
ishihiro@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michihiro Ono |
Organization
Sapporo Medical University
Division name
4th department of Internal Medicine
Zip code
Address
Minami 1-jo, Nishi 16-chome, Chuoku, Sapporo, Hokkaido
TEL
011-611-2111
Homepage URL
onomichihiroono34@yahoo.co.jp
Sponsor or person
Institute
Sapporo Medical University
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 30 | 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
Main results already published
Date of protocol fixation
| 2013 | Year | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 30 | 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
| 2013 | Year | 09 | Month | 27 | Day |
Last modified on
| 2015 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013554
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
