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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025709
Receipt No. R000029578
Scientific Title Liver failure after major hepatectomy for perihilar cholangiocarcinoma
Date of disclosure of the study information 2017/01/17
Last modified on 2019/02/14

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Basic information
Public title Liver failure after major hepatectomy for perihilar cholangiocarcinoma
Acronym Liver failure for PHCC
Scientific Title Liver failure after major hepatectomy for perihilar cholangiocarcinoma
Scientific Title:Acronym Liver failure for PHCC
Region
Japan

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

Objectives
Narrative objectives1 To investigate clinical factors for predicting liver failure until postoperative day 7.
Basic objectives2 Others
Basic objectives -Others Investigation for clinicopathological factors
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To investigate clinical characteristics for predicting liver failure after major hepatectomy for perihilar cholangiocarcinoma
Key secondary outcomes 5year survival rate in this cohort
Surgical result

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 performed major hepatectomy in our department (January 2000 until December 2015).
Key exclusion criteria Patients with HPD/Unresectable/surgery for reccurence/early death(within 14 days).
Target sample size 183

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takehiro Noji
Organization Hokkaido University
Division name GGraduate School of Medicine Gastroenterological Surgery II
Zip code
Address Kita15 Nishi7, Kita-ku, Sapporo city
TEL 011-716-1161
Email drnoji@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takehiro Noji
Organization Hokkaido University
Division name Graduate school of Medicine
Zip code
Address Kita15 Nishi7, Kita-ku, Sapporo city
TEL 011-716-1161
Homepage URL
Email drnoji@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Graduate School of Medicine
Institute
Department

Funding Source
Organization Hokkaido University Graduate School of Medicine
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
2017 Year 01 Month 17 Day

Related information
URL releasing protocol
Publication of results Published

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
2017 Year 01 Month 17 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective study from clinical information (Chart)

Management information
Registered date
2017 Year 01 Month 17 Day
Last modified on
2019 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029578

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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