UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Inquiry Search clinical trials

Name
UMIN ID

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013434
Receipt No. R000015606
Scientific Title Prospective study for treatment of common bile duct stones by biliary stent placement
Date of disclosure of the study information 2014/04/01
Last modified on 2017/03/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Prospective study for treatment of common bile duct stones by biliary stent placement
Acronym Prospective study for treatment of common bile duct stones by biliary stent placement
Scientific Title Prospective study for treatment of common bile duct stones by biliary stent placement
Scientific Title:Acronym 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
1st name
Middle name
Last name Yuzo Kodama
Organization Kyoto University
Division name Department of Gastroenterology and Hepatology
Zip code
Address 54 Kawaharacho, Shogoin, Sakyo-ku Kyoto
TEL 075-751-4319
Email kodamayu@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuki Ueda
Organization Kyoto University
Division name Department of Gastroenterology and Hepatology
Zip code
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)

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 04 Month 01 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 16 Day
Date of IRB
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

Other
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://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015606

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.