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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000018904
Receipt No. 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

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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
Email 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
Email puru.mimi@gmail.com

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021877

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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