UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Liver failure after major hepatectomy for perihilar cholangiocarcinoma
Title of the study (Brief title)	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	Takehiro Noji
Organization	Hokkaido University
Division name	GGraduate School of Medicine Gastroenterological Surgery II
Address	Kita15 Nishi7, Kita-ku, Sapporo city
TEL	011-716-1161
Email	drnoji@med.hokudai.ac.jp

Public contact
Name of contact person	Takehiro Noji
Organization	Hokkaido University
Division name	Graduate school of Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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