UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025709
Receipt number 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 12:13:39

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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 or person

Institute

Hokkaido University Graduate School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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