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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022916
Receipt No. R000026410
Scientific Title The effectiveness of EUS first-approach in cases of suspected common bile duct stones
Date of disclosure of the study information 2016/06/27
Last modified on 2016/06/27

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Basic information
Public title The effectiveness of EUS first-approach in cases of suspected common bile duct stones
Acronym EUS first
Scientific Title The effectiveness of EUS first-approach in cases of suspected common bile duct stones
Scientific Title:Acronym EUS first
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 the EUS first-approach in patient with suspicious of common bile duct stones
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes ・The adverse event rates in EUS alone group and EUS+ERCP combination group.
Key secondary outcomes ・The diagnostic ability of CBDS in EUS.
・The prognosis of ERCP omission group.
・The omission rates of ERCP due to EUS.

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 first EUS for suspected common bile duct stones between April 2012 and March 2016 at Gifu University Hospital.
Key exclusion criteria Patients with a history of gastric surgery.
Target sample size 100

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
Email 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
Email mrak5844@yahoo.co.jp

Sponsor
Institute Gifu University
Institute
Department

Funding Source
Organization None
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
2016 Year 06 Month 27 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
2016 Year 06 Month 27 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 27 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 first EUS for suspected common bile duct stones between April 2012 and March 2016 at Gifu University Hospital,retrospectively.

Management information
Registered date
2016 Year 06 Month 27 Day
Last modified on
2016 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026410

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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