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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010489
Receipt No. 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

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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
Email 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
Email YASUDAIC@aol.com

Sponsor
Institute BasketBall study group
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012262

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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