UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter randomized controlled trial of endoscopic treatment for conventional bile duct stone:ordinary sphincterotomy vs.papillary balloon dilation with minor sphincterotomy
Acronym	Multicenter randomized controlled trial of endoscopic treatment for conventional bile duct stone:ordinary sphincterotomy vs.papillary balloon dilation with minor sphincterotomy
Scientific Title	Multicenter randomized controlled trial of endoscopic treatment for conventional bile duct stone:ordinary sphincterotomy vs.papillary balloon dilation with minor sphincterotomy
Scientific Title:Acronym	Multicenter randomized controlled trial of endoscopic treatment for conventional bile duct stone:ordinary sphincterotomy vs.papillary balloon dilation with minor sphincterotomy
Region	Japan

Condition
Condition	Bile duct stones
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the utility and safety between the ordinary sphincterotomy and the minor sphincterotomy with balloon dilation in the ensoscopic treatment for common bile duct stones of <= 12 mm in diameter.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The necessity of mechanical lithotripsy
Key secondary outcomes	Fluoroscopy time, procedure time, complete stome removal, and complications.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	ordinary sphincterotomy
Interventions/Control_2	papillary balloon dilation with minor sphincterotomy
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Untreated Duodenum main 2)Bile duct stones of <= 12 mm 3)Written informed concent
Key exclusion criteria	1)Severe bleeding tendency 2)Post-operation of stomach, duodenum, bile duct 3)Non-adaptive case of endoscopic procedure 4)Other problem(s) in the opinion of the Investigator(s)
Target sample size	220

Research contact person
Name of lead principal investigator	1st name Takeshi Middle name Last name Hisa
Organization	Saku Central Hospital Advanced Care Center
Division name	Gastroenterology
Zip code	385-0051
Address	Nakagomi 3400-28, Saku, Nagano 385-0051 Japan
TEL	0267-62-8181
Email	hisa.takeshi@sakuhp.or.jp

Public contact
Name of contact person	1st name Miyuki Middle name Last name Niimi
Organization	Saku Central Hospital Advanced Care Center
Division name	Clinical Research Center
Zip code	385-0051
Address	3400-28 Nakagomi, Saku, Nagano 385-0051 JAPAN
TEL	0267-62-8181
Homepage URL
Email	ctroffice@sakuhp.or.jp

Sponsor
Institute	Saku Central Hospital Advanced Care Center
Institute
Department

Funding Source
Organization	Shinshu Public Utility Foundation for Promotion of Medical Sciences
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Saku Central Hospital Group Research Ethics Committee
Address	197 Usuda, Saku, Nagano,384-0393 JAPAN
Tel	0267-82-3131
Email	irboffice@sakuhp.or.jp

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	帯広厚生病院（北海道）

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 02 Day

Related information
URL releasing protocol
Publication of results	Unpublished

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	2015 Year 08 Month 25 Day
Date of IRB	2015 Year 09 Month 04 Day
Anticipated trial start date	2015 Year 10 Month 05 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 03 Month 31 Day
Date trial data considered complete	2021 Year 04 Month 16 Day
Date analysis concluded	2022 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date	2015 Year 11 Month 02 Day
Last modified on	2022 Year 11 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022188