UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027798 |
|---|---|
| Receipt number | R000031852 |
| Scientific Title | Comparison of long-term prognosis of EST and EPLBD against choledocholithiasis;a propensity score-based cohort analysis |
| Date of disclosure of the study information | 2017/06/17 |
| Last modified on | 2017/06/17 16:28:50 |
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Basic information
Public title
Comparison of long-term prognosis of EST and EPLBD against choledocholithiasis;a propensity score-based cohort analysis
Acronym
Long-term prognosis of EST and EPLBD
Scientific Title
Comparison of long-term prognosis of EST and EPLBD against choledocholithiasis;a propensity score-based cohort analysis
Scientific Title:Acronym
Long-term prognosis of EST and EPLBD
Region
| Japan |
Condition
Condition
Common bile duct stone
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of long-term prognosis of EST and EPLBD against choledocholithiasis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
long-term prognosis of EST and EPLBD
Key secondary outcomes
Success rate and adverse event of EST and EPLBD
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
Patients who underwent EST or EPLBD for common bile duct stone between October 1999 and December 2015 at Gifu University Hospital and related facilities.
Key exclusion criteria
(1) prior history of EST or EPLBD, (2) pancreatobiliary malignancies, (3) bile duct stricture, including primary sclerosing cholangitis, (4) concurrent presence of intrahepatic stone, (5) pre cut or infundibulotomy, (6) uncorrected coagulopathy
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuji Iwashita |
Organization
Gifu University Hospital
Division name
First Department of Internal Medicine
Zip code
Address
1-1 Yanagido Gifu city
TEL
058-230-6308
takuji@w7.dion.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akinori Maruta |
Organization
Gifu University Hospital
Division name
First Department of Internal Medicine
Zip code
Address
1-1 Yanagido Gifu city
TEL
058-230-6308
Homepage URL
mrak5844@yahoo.co.jp
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Gifu Municipal Hospital
Gifu Prefectural General Medical Center
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
| 2017 | Year | 06 | Month | 17 | 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
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate patients who underwent EST or EPLBD for common bile duct stone between October 1999 and December 2015 at Gifu University Hospital and related facilities,retrospectively.
Management information
Registered date
| 2017 | Year | 06 | Month | 17 | Day |
Last modified on
| 2017 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031852
