UMIN-CTR Clinical Trial

Basic information
Public title	A prospective, randomized, controlled trial to compare the effectiveness of endoscopic sphincterotomy with endoscopic papillary large balloon dilation for removal of bile duct stones
Acronym	EST vs EPLBD for removal of bile ductal stones
Scientific Title	A prospective, randomized, controlled trial to compare the effectiveness of endoscopic sphincterotomy with endoscopic papillary large balloon dilation for removal of bile duct stones
Scientific Title:Acronym	EST vs EPLBD for removal of bile ductal stones
Region	Japan

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

Objectives
Narrative objectives1	To compare the effectiveness of EST with EPLBD for removal of common bile duct stones
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	1) total time for removal of bile duct stones 2) total sessions of ERCP
Key secondary outcomes	1)early and late complication rates 2)recurrence rate

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	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	EST group 30 cases 5/8/2014-5/7/2015
Interventions/Control_2	EPLBD group 30 cases 5/8/2014-5/7/2015
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	60 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. A minor diameter of stone is larger than 10 mm. 2. Patients in whom papilla of Vater have not been treated endoscopically or surgically. 3. In emergent cases, patients in whom underwent EST or EBD within a week. 4. Patients in whom CT is performed before endoscopic procedures. 5. Patients in whom written informed consent is obtained.
Key exclusion criteria	1. Patients who underwent reconstruction of upper digestive tract(Bil II or RY) 2. Patients who underwent EST or EPBD previously. 3. Performance status is 4. 4. ASA physical status is more than 3. 5. Patients who undergo hemodaialysis. 6. Judged as inadequate for this study by the investigator. 7. Patients who become serious after first procedure.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kiyohito Tanaka
Organization	Kyoto 2nd red cross hospital
Division name	Gastroenterology and hepatology
Zip code
Address	355-5 Haruobicho Kamannza Marutamachi Kamigyo ward Kyoto city
TEL	075-231-5171
Email	seijin7705@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Kazuhide Higuchi
Organization	Osaka Medical College
Division name	2nd department of internal medicine
Zip code
Address	2-7Daigakucho Takatsuki city Osaka
TEL	072-683-1221
Homepage URL
Email	higuchi@poh.osaka-med.ac.jp

Sponsor
Institute	Kansai Endoscopic Device Selection (EDS) Working Group
Institute
Department

Funding Source
Organization	Kansai Endoscopic Device Selection (EDS) Working Group
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2014 Year 05 Month 08 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	Terminated
Date of protocol fixation	2014 Year 03 Month 11 Day
Date of IRB	2022 Year 11 Month 10 Day
Anticipated trial start date	2014 Year 05 Month 08 Day
Last follow-up date	2022 Year 11 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 05 Month 06 Day
Last modified on	2022 Year 11 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016200