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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019927
Receipt No. R000023007
Scientific Title Evaluation of surgical results for concomitant hepatic artery resection in perihilar cholangiocarcinoma
Date of disclosure of the study information 2015/11/25
Last modified on 2019/02/14

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Basic information
Public title Evaluation of surgical results for concomitant hepatic artery resection in perihilar cholangiocarcinoma
Acronym Evaluation of surgical results for concomitant hepatic artery resection in perihilar cholangiocarcinoma
Scientific Title Evaluation of surgical results for concomitant hepatic artery resection in perihilar cholangiocarcinoma
Scientific Title:Acronym Evaluation of surgical results for concomitant hepatic artery resection 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 surgical results of concomitant hepatic artery resection in perihilar cholangiocarcinoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Short and long term outcome
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 Patietns with perihilar cholangiocarcinoma in Hokkaido University Hospital (department of Surgery II or Gastroeterological surgery II), during period from January 2000 to September 2015.
Key exclusion criteria Palliative intention, surgery after chemotherapy.
Target sample size 220

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takehiro Noji
Organization Hokkaido University Graduate School of Medicine
Division name Gastroenterological Surgery II
Zip code
Address Kita15 Nishi7, Kita-ku, Sapporo city, Hokkaido
TEL 011-716-2111
Email drnoji@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takehiro Noji
Organization Hokkaido University Graduate School of Medicine
Division name Gastroenterological Surgery II
Zip code
Address Kita15 Nishi7, Kita-ku, Sapporo city, Hokkaido
TEL 011-716-2111
Homepage URL
Email drnoji@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Graduate school of Medicine, Department of Gastroenterological surgery II
Institute
Department

Funding Source
Organization Hokkaido University Graduate school of Medicine, Department of Gastroenterological surgery II
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
2015 Year 11 Month 25 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
2015 Year 11 Month 25 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Among 220 patients with perihilar cholangiocarcinoma, 11 patients were excluded. We are evaluating prognosis and postoperative complication.

Management information
Registered date
2015 Year 11 Month 25 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=R000023007

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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