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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036316
Receipt No. R000041357
Scientific Title The relationship between waiting time after preoperative portal vein embolism and mortality with hepatic failure in perihilar cholangiocarcinoma patients
Date of disclosure of the study information 2019/08/01
Last modified on 2020/06/24

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Basic information
Public title The relationship between waiting time after preoperative portal vein embolism and mortality with hepatic failure in perihilar cholangiocarcinoma patients
Acronym Evaluation of wating time after portal vein embolization
Scientific Title The relationship between waiting time after preoperative portal vein embolism and mortality with hepatic failure in perihilar cholangiocarcinoma patients
Scientific Title:Acronym Evaluation of wating time after portal vein embolization
Region
Japan

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

Objectives
Narrative objectives1 To evaluate relation between pre operative poral vein embolization (pre PE) and post operative liver failure, mortality. And also evaluate relation between wating time after pre PE and post operative complications.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 90days mortality
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 with perihilar cholangiocarcinoma who underwent surgery in Hokkaido University hospital department of gastroenterological surgery II from January 1st 2000 to December 31 2018.
Key exclusion criteria Without agreement for attendance
Target sample size 222

Research contact person
Name of lead principal investigator
1st name Takehiro
Middle name
Last name Noji
Organization Hokkaido University hospital
Division name Gastroenterological surgery II
Zip code 060-8638
Address Kita15 Nishi7, Kita-ku, Sapporo city, Hokkaido Japan
TEL 0117067714
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 060-8638
Address Kita15 Nishi7, Kita-ku, Sapporo city, Hokkaido Japan
TEL 0117067714
Homepage URL
Email drnoji@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital, Gastroenterological surgery II
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Hokkaido University Faculty of Medicine

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

IRB Contact (For public release)
Organization HokkaidonUniversity Hospital IRB
Address kita 14 Nishi 5, Kita-ku, Sapporo city
Tel 0117161161
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 08 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 183
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
2019 Year 03 Month 27 Day
Date of IRB
2019 Year 06 Month 19 Day
Anticipated trial start date
2019 Year 03 Month 27 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Evaluate patietnt's characteristics and surigical outcome, retrospectively.

Management information
Registered date
2019 Year 03 Month 27 Day
Last modified on
2020 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041357

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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