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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037533
Receipt No. R000042789
Scientific Title Affect of surgical margin in perihilar cholangiocarcinoma
Date of disclosure of the study information 2019/07/31
Last modified on 2019/07/29

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Basic information
Public title Affect of surgical margin in perihilar cholangiocarcinoma
Acronym Affect of surgical margin in perihilar cholangiocarcinoma
Scientific Title Affect of surgical margin in perihilar cholangiocarcinoma
Scientific Title:Acronym Affect of surgical margin in perihilar cholangiocarcinoma
Region
Japan

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

Objectives
Narrative objectives1 To evaluate short and long term surgical results of the patiens with perihilar cholangiocarcinoma who had underwent radical surgery on limit of the resection.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 5 year survival rate
Key secondary outcomes R0 resection rate
Morbidity rate
Mortality rate

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 Perihilar cholagiocarcinoma patients who underwent surgery from 2004 to 2018 in Hokkaido University Hospital Gastroenterological surgery II (or Surgery II)
Key exclusion criteria 1 Unresected patients
2 Surgery for recurrent site
3 HPD cases
4 Resercher's sekection for insufficient for study
Target sample size 212

Research contact person
Name of lead principal investigator
1st name Takehiro
Middle name
Last name Noji
Organization Hokkaido University Faculty of Medicine
Division name Gastroenterological surgery II
Zip code 0608638
Address Kita15 Nishi7, Kita-ku, Sapporo city
TEL 011-706-7714
Email drnoji@med.hokudai.ac.jp

Public contact
Name of contact person
1st name Takehiro
Middle name
Last name Noji
Organization Hokkaido University Faculty of Medicine
Division name Gastroenterological surgery II
Zip code 0608638
Address Kita15 Nishi 7
TEL 011-706-7714
Homepage URL
Email drnoji@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Faculty of Medicine, Gastroenterological surgery II
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Hokkaido

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

IRB Contact (For public release)
Organization Hokkaido University Hospital IRB
Address Kita14 Nishi5, Kita-ku, Sapporo city
Tel 011-706-7636
Email crjimu@huhp.hokudai.ac.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
2019 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 212
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 No longer recruiting
Date of protocol fixation
2019 Year 07 Month 30 Day
Date of IRB
2019 Year 08 Month 30 Day
Anticipated trial start date
2019 Year 07 Month 30 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective observation study. Patient's charcteristics (such a gender, age, surgical procedure, operation time, bleeding, morbidity, mortality, R0 resection rate, and survival)

Management information
Registered date
2019 Year 07 Month 29 Day
Last modified on
2019 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042789

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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