UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized controlled trial of prior minimal endoscopic spincteroplasty /EST + endoscopic ballon sphincteroplasty /EBS and EST in a choledocholith treatment
Title of the study (Brief title)	Randomized controlled trial of prior minimal EST + EBS and EST in a choledocholith treatment
Region	Japan

Condition
Condition	choledocholith
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We investigated the efficacy of prior minimal EST+ EBS in a choledocholith treatment
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Incidence of complication after the procedure in 7days
Key secondary outcomes	The stone clearance rate, and the number of ERCPs required for complete stone clearance.

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	minimal EST+EBS group
Interventions/Control_2	EST group
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	1,the presence of choledocholith < 8mm in CT,MRI,US,EUS within a month 2ECOS PS is 0 or 1 3Criteria blood test Neutrophils < 1500/ml,Plt<80000,Hb>9.0, Cre<1.5mg/dl,AST/ALT<92/107,T-Bil<2mg/dL, Alb2.8g/dL,PT-INR<1.5 4,the patient who is expected to live more than three month
Key exclusion criteria	1,a history of EST or EBS 2,a history of Billroth 2 or Roux-en-Yanatomy 3,pancreatobiliary malignancy 4,choledochoduodenalfistula , concurrent hepatolithiasis 5,the patient who has a heart disease .a history of congested heart failure, cardiac infarction .a history of serious arrhythmia, hypertention .a history of coronary disease 6,the patient who has a mental disease
Target sample size	300

Research contact person
Name of lead principal investigator	Jin Kan Sai
Organization	Juntendo University Hospital
Division name	Department of Gastroenterology
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL	03-3813-3111(70227)
Email	ivo@juntendo.ac.jp

Public contact
Name of contact person	Ryo Kanazawa
Organization	Juntendo University Hospital
Division name	Department of Gastroenterology
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL	03-3813-3111(70226)
Homepage URL
Email	rkanaza@juntendo.ac.jp

Sponsor
Institute	Juntendo University Hospital Department of Gastroenterology
Institute
Department

Funding Source
Organization	Juntendo University Hospital Department of Gastroenterology
Organization
Division
Category of Funding Organization	Self funding
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	2016 Year 03 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 12 Month 23 Day
Anticipated trial start date	2016 Year 03 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	2016 Year 01 Month 25 Day
Last modified on	2018 Year 01 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023918