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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040708
Receipt No. R000045920
Scientific Title The effectiveness of magnetic resonance cholangioscopy for the preoperative superficial ductal spread diagnosis of perihilar cholangiocarcinoma
Date of disclosure of the study information 2020/06/09
Last modified on 2020/06/09

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Basic information
Public title The effectiveness of magnetic resonance cholangioscopy for the preoperative superficial ductal spread diagnosis of perihilar cholangiocarcinoma
Acronym The effectiveness of MRCS for the preoperative superficial ductal spread diagnosis of perihilar cholangiocarcinoma
Scientific Title The effectiveness of magnetic resonance cholangioscopy for the preoperative superficial ductal spread diagnosis of perihilar cholangiocarcinoma
Scientific Title:Acronym The effectiveness of MRCS for the preoperative superficial ductal spread diagnosis of perihilar cholangiocarcinoma
Region
Japan

Condition
Condition Perihilar cholangiocarcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the accuracy of MRCS for the preoperative superficial ductal spread diagnosis of perihilar cholangiocarcinoma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate the accuracy of MRCS for the preoperative superficial ductal spread diagnosis of the perihilar cholangiocarcinoma.
Key secondary outcomes The comparison of MRCS and ERC/ peroral cholangioscopy/ CT for the preoperative superficial ductal spread of the perihilar cholangiocarcinoma.
ERC related adverse events

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
100 years-old >=
Gender Male and Female
Key inclusion criteria The resectable the perihilar cholangiocarcinoma cases with evaluated MRCS before surgical treatment.
Key exclusion criteria Less than 20-years-old
the patients who evaluated MRI after biliary drainage
The patients who are otherwise judged by the investigator to be ineligible to participate in the study.
Target sample size 16

Research contact person
Name of lead principal investigator
1st name Mitsuru
Middle name
Last name Okuno
Organization Gifu Municipal Hospital
Division name Department of Gastroenterology
Zip code 5008513
Address 7-1 Kasima-cho, Gifu city, Gifu
TEL 0582511101
Email mkobdkl@yahoo.co.jp

Public contact
Name of contact person
1st name Mitsuru
Middle name
Last name Okuno
Organization Gifu Municipal Hospital
Division name Department of Gastroenterology
Zip code 5008513
Address 7-1 Kasima-cho, Gifu city, Gifu
TEL 0582511101
Homepage URL
Email mkobdkl@yahoo.co.jp

Sponsor
Institute Gifu municipal hospital
Institute
Department

Funding Source
Organization Gifu municipal hospital
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 Gifu municipal hospital
Address 7-1 Kasima-cho, Gifu city, Gifu
Tel 0582511101
Email mkobdkl@yahoo.co.jp

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
2020 Year 06 Month 09 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 Open public recruiting
Date of protocol fixation
2020 Year 03 Month 26 Day
Date of IRB
2020 Year 03 Month 26 Day
Anticipated trial start date
2020 Year 03 Month 26 Day
Last follow-up date
2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2020 Year 06 Month 09 Day
Last modified on
2020 Year 06 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045920

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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