UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013434 |
|---|---|
| Receipt number | 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 18:04:59 |
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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
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
tueda@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Kyoto University
Institute
Department
Personal name
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
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
Value
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 | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
