UMIN-CTR Clinical Trial

Basic information
Public title	The correlation between the portal vein pressure after major hepatectomy and postoperative liver failure
Acronym	The correlation between the portal vein pressure and postoperative liver failure
Scientific Title	The correlation between the portal vein pressure after major hepatectomy and postoperative liver failure: a prospective observational study
Scientific Title:Acronym	The correlation between the portal vein pressure after major hepatectomy and postoperative liver failure
Region	Japan

Condition
Condition	Perihilar cholangiocarcinoma or metastatic liver cancer without cirrhosis
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To examine the efficacy of portal vein pressure measurement before and after portal vein embolization or major hepatectomy to predict postoperative liver failure.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The correlation of the incidence of postoperative liver failure and the elevation of portal vein pressure after hepatectomy.
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	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Patients who are diagnosed with perihilar cholangiocarcinoma or metastic liver cancer without cirrhosis 2) Patients who undergo portal vein embolization 3) Performance status should be 0-1. 4) Patients who understand the explanation of this study
Key exclusion criteria	1) Patients with cirrhosis 2) Patients who was considered inappropriate by doctors
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yu Middle name Last name Takahashi
Organization	The Cancer Institute Hospital Of JFCR
Division name	Department of Gastroenterological Surgery
Zip code	135-8550
Address	3-8-31 Ariake, Kotoku, Tokyo, Japan
TEL	03-3520-0111
Email	yu.takahashi@jfcr.or.jp

Public contact
Name of contact person	1st name Yoshihiro Middle name Last name Ono
Organization	The Cancer Institute Hospital Of JFCR
Division name	Department of Gastroenterological Surgery
Zip code	135-8550
Address	3-8-31 Ariake, Kotoku, Tokyo, Japan
TEL	03-3520-0111
Homepage URL
Email	yoshihiro.ono@jfcr.or.jp

Sponsor
Institute	The Cancer Institute Hospital Of JFCR
Institute
Department

Funding Source
Organization	The Cancer Institute Hospital Of JFCR
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Cancer Institute Hospital Of JFCR
Address	3-8-31 Ariake, Kotoku, Tokyo, Japan
Tel	03-3520-0111
Email	yoshihiro.ono@jfcr.or.jp

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	2019 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

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	Preinitiation
Date of protocol fixation	2019 Year 07 Month 23 Day
Date of IRB
Anticipated trial start date	2019 Year 08 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2019 Year 07 Month 23 Day
Last modified on	2019 Year 07 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042701

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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