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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036357
Receipt No. R000041423
Scientific Title Randamized control study of EUS versus MRCP for choledocholithiasis that can not be diagnosed by CT.
Date of disclosure of the study information 2019/04/01
Last modified on 2019/04/04

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Basic information
Public title Randamized control study of EUS versus MRCP for choledocholithiasis that can not be diagnosed by CT.
Acronym Randamized control study of EUS versus MRCP for choledocholithiasis that can not be diagnosed by CT.
Scientific Title Randamized control study of EUS versus MRCP for choledocholithiasis that can not be diagnosed by CT.
Scientific Title:Acronym Randamized control study of EUS versus MRCP for choledocholithiasis that can not be diagnosed by CT.
Region
Japan

Condition
Condition choledocholithiasis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the utility of between EUS and MRCP for choledocholithiasis that can not be diagnosed by CT.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes additional investigation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 EUS group:Patient who can not be diagnosed by MRCP for choledocholithiasis
Interventions/Control_2 MRCP group:Patient who can not be diagnosed by EUS for choledocholithiasis
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
89 years-old >=
Gender Male and Female
Key inclusion criteria 1.Patients who can not be diagnosed choledocholithiasis by CT.
2.Patients who meet the suspected diagnosis or diagnostic criteria according to Tokyo Guidelines 2018(TG18).
3.Patients with "mild" or "moderate" acute cholangitis,which is defined by TG18.
4.Patients with written informed consent.
Key exclusion criteria 1.Patients who have metal allergy.
2.Patients who have iron hypersensitivity.
3.Altered upper GI anatomy.
4.Patients who have gastrointestinal hemorrhage.
5.Pregnant,unwilling to practice contraception during the study, or lactating female.
6.Patients with "severe" acute cholangitis,which is defined by TG18.
7.Patients considered ineligible for this study.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Masato
Middle name
Last name Suzuki
Organization Yokohama Rosai Hospital
Division name Department of Gastroenterology
Zip code 222-0036
Address 3211,Kozukue-cho,Kouhoku-ku,Yokohama-shi,Kanagawa
TEL 045-474-8111
Email d07sm056@gmail.com

Public contact
Name of contact person
1st name Masato
Middle name
Last name Suzuki
Organization Yokohama Rosai Hospital
Division name Department of Gastroenterology
Zip code 222-0036
Address 3211,Kozukue-cho,Kohoku-ku,Yokohama-city,Kanagawa
TEL 045-474-8111
Homepage URL
Email d07sm056@gmail.com

Sponsor
Institute Yokohama Rosai Hospital,Department of Gastroenterology
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Yokohama Rosai Hospital
Address 3211,Kozukue-cho,Kouhoku-ku,Yokohama-shi,Kanagawa
Tel 045-474-8111
Email none

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
2019 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 Preinitiation
Date of protocol fixation
2019 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 03 Month 31 Day
Last modified on
2019 Year 04 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041423

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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