UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective randomized study of endoscopic biliary stone extraction using a basket or a balloon catheter
Title of the study (Brief title)	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	Ichiro Yasuda
Organization	Gifu University Hospital
Division name	First Dept. of Internal Medicine
Address	1-1 Yanagido, Gifu 501-1194, Japan
TEL	058-230-6308
Email	yasudaich@gmail.com

Public contact
Name of contact person	Ichiro Yasuda
Organization	Gifu University Hospital
Division name	First Dept. of Internal Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 04 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000012262