UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Posthepatectomy portal vein pressure and postoperative complications after major liver resection
Title of the study (Brief title)	Posthepatectomy portal vein pressure and postoperative complications after major liver resection
Region	Japan

Condition
Condition	Liver cancer Bile duct cancer
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We evaluate whether how much portal vein pressure induce posthepatectomy liver failure.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	prehepatectomy portal vein pressure, posthepatectomy poretal vein pressure
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	We measure prehepatectomy and posthepatectomy portal vein pressure.
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	major hepatectomy
Key exclusion criteria	cirrhotic liver
Target sample size	100

Research contact person
Name of lead principal investigator	Yoichi Ishizaki
Organization	Juntendo University School
Division name	Hepatobiliary-Pancreatic Surgery
Address	2-1-1 Hongo,Bunkyo-ku,Tokyo
TEL	03-3813-3111
Email	ishizaki@juntendo.ac.jp

Public contact
Name of contact person	Shinichi Matsudaira
Organization	Juntendo University School
Division name	Hepatobiliary-Pancreatic Surgery
Address	2-1-1 Hongo,Bunkyo-ku,Tokyo
TEL	03-3813-3111
Homepage URL
Email	smatuda@juntendo.ac.jp

Sponsor
Institute	Department of Hepatobiliary-Pancreatic Surgery,Juntendo University School of Medicen
Institute
Department

Funding Source
Organization	Department of Hepatobiliary-Pancreatic Surgery,Juntendo University School of Medicen
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	2014 Year 08 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 08 Month 01 Day
Anticipated trial start date	2014 Year 08 Month 01 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 07 Month 31 Day
Last modified on	2017 Year 07 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017124