UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study for treatment of common bile duct stones by biliary stent placement
Title of the study (Brief title)	Prospective study for treatment of common bile duct stones by biliary stent placement
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	To evaluate efficacy of biliary stent placement for clearance of common bile duct stones
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Clearance rate of common bile duct stones three months after biliary stent placement
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	placement of biliary stent
Interventions/Control_2
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	70 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Cases with jaundice or hepatobiliary abnormalities in blood test within a week 2.Cases with common bile duct stones confirmed by diagnostic imaging;CT, MRI, abdominal ultrasonography or endoscopic ultrasonography, or clinically suspected of common bile duct stones as a cause of jaundice or hepatobiliary abnormalities. 3.70 years old or less. 4.Bile duct diameter is 10 mm or less.
Key exclusion criteria	1.Cases that informed consent can not be obtained from 2.Cases who have already been treated by duodenal papilla sphincterotomy 3.Cases with biliary tract malignancy 4.Cases with Bilroth-2 method or Roux-en-Y gastric resection reconstruction 5.Cases who refuse cholecystectomy 6.Cases with choledochoduodenum fistula 7.Cases with benign bile duct stenosis 8.Cases that the physician think the study is inappropriate for
Target sample size	80

Research contact person
Name of lead principal investigator	Yuzo Kodama
Organization	Kyoto University
Division name	Department of Gastroenterology and Hepatology
Address	54 Kawaharacho, Shogoin, Sakyo-ku Kyoto
TEL	075-751-4319
Email	kodamayu@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Tatsuki Ueda
Organization	Kyoto University
Division name	Department of Gastroenterology and Hepatology
Address	54 Kawaharacho, Shogoin, Sakyo-ku Kyoto
TEL	075-751-4319
Homepage URL
Email	tueda@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Department of Gastroenterology and Hepatology, Kyoto University
Institute
Department

Funding Source
Organization	Kyoto university
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	2014 Year 04 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 03 Month 16 Day
Anticipated trial start date	2014 Year 04 Month 01 Day
Last follow-up date	2016 Year 09 Month 21 Day
Date of closure to data entry	2016 Year 09 Month 21 Day
Date trial data considered complete	2016 Year 09 Month 21 Day
Date analysis concluded	2016 Year 09 Month 21 Day

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

Management information
Registered date	2014 Year 03 Month 16 Day
Last modified on	2017 Year 03 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015606