UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018904 |
|---|---|
| Receipt number | R000021877 |
| Scientific Title | Long term study of choledochoduodenostomy, choledochojejunostomy and transduodenal sphincteroplasty for 263 bile duct stone cases |
| Date of disclosure of the study information | 2015/09/03 |
| Last modified on | 2015/09/03 20:07:30 |
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Basic information
Public title
Long term study of choledochoduodenostomy, choledochojejunostomy and transduodenal sphincteroplasty for 263 bile duct stone cases
Acronym
Long term study of choledochoduodenostomy, choledochojejunostomy and transduodenal sphincteroplasty for 263 bile duct stone cases
Scientific Title
Long term study of choledochoduodenostomy, choledochojejunostomy and transduodenal sphincteroplasty for 263 bile duct stone cases
Scientific Title:Acronym
Long term study of choledochoduodenostomy, choledochojejunostomy and transduodenal sphincteroplasty for 263 bile duct stone cases
Region
| Japan |
Condition
Condition
Bile duct stone
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
we retrospectively examined the long-term study of CD, CJ and TDP for CBDS.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
background comparison (Age, sex, primary bile duct stones and follow up term), hospital mortality, long term study
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who underwent surgery for CBDS from 1967 to 2013 (for 46 years) at our institution
Key exclusion criteria
No
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masakazu Yamamoto |
Organization
Tokyo Women's Medical University
Division name
Department of Surgery, Institute of Gastroenterology,
Zip code
Address
Kawadacho 8-1 Shinjuku-ku Tokyo
TEL
0333538111
puru.mimi@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mimi Okano |
Organization
Tokyo Women's Medical University
Division name
Department of Surgery, Institute of Gastroenterology,
Zip code
Address
Kawadacho 8-1 Shinjuku-ku Tokyo
TEL
0333538111
Homepage URL
puru.mimi@gmail.com
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University
Organization
Division
Category of Funding Organization
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
| 2015 | Year | 09 | Month | 03 | 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
Main results already published
Date of protocol fixation
| 2014 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Yes
Management information
Registered date
| 2015 | Year | 09 | Month | 03 | Day |
Last modified on
| 2015 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021877
