UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective comparative study of endoscopic papillary large balloon dilatation and endoscopic sphincterotomy and endoscopic papillary large balloon dilatation with endoscopic sphincterotomy
Title of the study (Brief title)	Prospective comparative study of endoscopic papillary large balloon dilatation and endoscopic sphincterotomy and endoscopic papillary large balloon dilatation with endoscopic sphincterotomy
Region	Japan

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

Objectives
Narrative objectives1	Prospective comparative study of endoscopic papillary large balloon dilatation and endoscopic sphincterotomy and endoscopic papillary large balloon dilatation with endoscopic sphincterotomy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	complete stone removal rate
Key secondary outcomes

Base
Study type

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	EST
Interventions/Control_2	EPLBD
Interventions/Control_3	EPLBD with EST
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	40 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	common bile duct stones with the diameter of CBD 12mm<
Key exclusion criteria	common bile duct stones with the diameter of CBD 12mm>
Target sample size	60

Research contact person
Name of lead principal investigator	Yamamoto Ryuichi
Organization	Saitama Medical Center, Saitama Medical College
Division name	Gastroenterology and Hepatology
Address	1981, Kamoda, Kawagoe city
TEL
Email

Public contact
Name of contact person
Organization	Saitama Medical Center, Saitama Medical College
Division name	Gastroenterology and Hepatology
Address	1981, Kamoda, Kawagoe city
TEL
Homepage URL
Email

Sponsor
Institute	Saitama Medical Center, Saitama Medical College
Institute
Department

Funding Source
Organization	Saitama Medical Center, Saitama Medical College
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2013 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 04 Month 01 Day
Anticipated trial start date	2013 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 03 Month 27 Day
Last modified on	2018 Year 09 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012079