UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinicopathological factors in hepatocellular carcinoma with microscopic portal vein invasion.
Title of the study (Brief title)	Clinicopathological factors in HCC with vp1.
Region	Japan

Condition
Condition	Hepatocellular carcinoma
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Analysis of clinicopathological factors in HCC with vp1
Basic objectives2	Others
Basic objectives -Others	Analysis of clinicopathological factors
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Prognostic factors for survival and recurrence
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	1 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	initial hepatectomy for HC with vp1
Key exclusion criteria	exept for initial hepatectomy
Target sample size

Research contact person
Name of lead principal investigator	Toshiya Kamiyama
Organization	Hokkaido University
Division name	Gastroenterological surgery I
Address	N-15, W-7, Kita-Ku, Sapporo
TEL	011-706-5927
Email	t-kamiya@med.hokudai.ac.jp

Public contact
Name of contact person	Shingo Shimada
Organization	Hokkaido University
Division name	Gastroenterological surgery I
Address	N-15, W-7, Kita-Ku, Sapporo
TEL	011-706-5927
Homepage URL
Email	shingoshimada1979@true.ocn.ne.jp

Sponsor
Institute	Department of Gastroenterological surgery I, Hokkaido University
Institute
Department

Funding Source
Organization	Department of Gastroenterological surgery I, Hokkaido University
Organization
Division
Category of Funding Organization
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	2015 Year 07 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	1991 Year 01 Month 01 Day
Anticipated trial start date	1991 Year 01 Month 01 Day
Last follow-up date	2017 Year 03 Month 14 Day
Date of closure to data entry	2017 Year 03 Month 14 Day
Date trial data considered complete	2017 Year 03 Month 14 Day
Date analysis concluded	2017 Year 03 Month 14 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	Even if no portal venous invasion is detectable in HCC patients preoperatively, a PIVKA-II above 100 mAU/ml, tumor size above 5 cm, and a confluent lesion indicate a high risk of mPVI. ALR should be considered for the patients with these characteristics because it is a favorable prognostic factor in these cases with mPVI.

Management information
Registered date	2015 Year 06 Month 10 Day
Last modified on	2017 Year 03 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020688