UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010489 |
|---|---|
| Receipt number | R000012262 |
| Scientific Title | A prospective randomized study of endoscopic biliary stone extraction using a basket or a balloon catheter |
| Date of disclosure of the study information | 2013/06/01 |
| Last modified on | 2016/10/16 10:58:02 |
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Basic information
Public title
A prospective randomized study of endoscopic biliary stone extraction
using a basket or a balloon catheter
Acronym
Basket vs. Balloon in biliary stone extraction
Scientific Title
A prospective randomized study of endoscopic biliary stone extraction
using a basket or a balloon catheter
Scientific Title:Acronym
Basket vs. Balloon in biliary stone extraction
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 success rate of endoscopic clearance of biliary stone using a basket and a balloon catheter
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Rate of complete clearance of biliary stone at 10 minutes
Key secondary outcomes
Complications related to the procedures
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
A group undergo endoscopic extraction of bile duct stones using a basket
Interventions/Control_2
A group undergo endoscopic extraction of bile duct stones using a 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
Patients with biliary stones whose diagnosis was confirmed by ERCP. (no limitation of stone number)
Key exclusion criteria
1. Patients with previous gastrectomy
except for Billroth-I reconstruction
2. Patients with bile duct stenosis
3. Recurrent stone cases in whom EST is not required (with widely opened biliary orifice)
4. Age below 20 years
5. Patients with bleeding tendency
6. Patients whose informed consent could not be obtained.
7. In case that doctors judged inappropriate for the entry
Target sample size
170
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro Yasuda |
Organization
Gifu University Hospital
Division name
First Dept. of Internal Medicine
Zip code
Address
1-1 Yanagido, Gifu 501-1194, Japan
TEL
058-230-6308
yasudaich@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ichiro Yasuda |
Organization
Gifu University Hospital
Division name
First Dept. of Internal Medicine
Zip code
Address
1-1 Yanagido, Gifu 501-1194, Japan
TEL
058-230-6308
Homepage URL
YASUDAIC@aol.com
Sponsor or person
Institute
BasketBall study group
Institute
Department
Personal name
Funding Source
Organization
BasketBall study group
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Gifu Municipal Hospital, Gifu Prefectural Medical Center, Kurume University, Nagoya Second Red Cross Hospital, Toyama Prefectural Central Hospital
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
岐阜大学第一内科(岐阜県)、岐阜市民病院消化器内科(岐阜県)、岐阜県総合医療センター消化器科(岐阜県)、久留米大学消化器内科(福岡県)、名古屋第二赤十字病院消化器内科(愛知県)、富山県立中央病院消化器科(富山県)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | 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
| 2013 | Year | 04 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 04 | Month | 15 | Day |
Date trial data considered complete
| 2015 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 14 | Day |
Last modified on
| 2016 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012262
