UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of risk factors for the recurrence of bile duct stones in patients treated with endoscopy
Title of the study (Brief title)	Analysis of risk factors for the recurrence of bile duct stones
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 identify significant risk factors for the recurrence of bile duct stones
Basic objectives2	Others
Basic objectives -Others	To identify patients' risk factors for the recurrence of bile duct stones
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of recurrence of common bile duct stones
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients who were hospitalized for common bile duct stones
Key exclusion criteria	Patients who did not undergo endoscopic removal of stones Patients who had concomitant pancreaticobiliary malignancy
Target sample size	400

Research contact person
Name of lead principal investigator	Akihiko Satoh
Organization	South Miyagi Medical Center
Division name	Department of Gastroenterology
Address	38-1 Aza-Nishi, Ohgawara, Miyagi 989-1253, Japan
TEL	+81-224-51-5500
Email	asato@bf7.so-net.ne.jp

Public contact
Name of contact person	Akihiko Satoh
Organization	South Miyagi Medical Center
Division name	Department of Gastroenterology
Address	38-1 Aza-Nishi, Ohgawara, Miyagi 989-1253, Japan
TEL	+81-224-51-5500
Homepage URL
Email	asato@bf7.so-net.ne.jp

Sponsor
Institute	South Miyagi Medical Center
Institute
Department

Funding Source
Organization	South Miyagi Medical Center
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	2019 Year 01 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 08 Month 01 Day
Anticipated trial start date	2012 Year 09 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	Partially published
URL releasing results
Results	Saline solution irrigation with a specially designed biliary catheter reduces the recurrence of common bile duct stone
Other related information	Retrospective observational study

Management information
Registered date	2019 Year 01 Month 30 Day
Last modified on	2019 Year 01 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040692