UMIN-CTR Clinical Trial

Basic information
Public title	Study of liver surgical anatomy using 3D simulation software
Acronym	Study of liver surgical anatomy using 3D simulation software
Scientific Title	Study of liver surgical anatomy using 3D simulation software
Scientific Title:Acronym	Study of liver surgical anatomy using 3D simulation software
Region	Japan

Condition
Condition	portal vein thrombosis
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	E-CT was performed on the first day after liver resection, and immediate anticoagulant therapy was started when PVT was detected. We assessed the frequency, predictive factors, and efficacy of early intervention for PVT.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Frequency of portal vein thrombosis Effects and adverse events of anticoagulant therapy
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who underwent liver resection for primary liver cancer.
Key exclusion criteria	Metastatic liver cancer, bile duct or portal vein reconstruction, laparoscopic surgery, contrast medium allergy, renal dysfunction, or thrombus requiring anticoagulant therapy.
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Shintaro Middle name Last name Yamazaki
Organization	Nihon University School of Medicine
Division name	Department of Digestive Surgery
Zip code	1738610
Address	30-1 Oyaguchikami-machi, Itabashi-ku, Tokyo
TEL	+81-3-3972-8111
Email	yamazaki-nmed@umin.ac.jp

Public contact
Name of contact person	1st name Nao Middle name Last name Yoshida
Organization	Nihon University School of Medicine
Division name	Department of Digestive Surgery
Zip code	1738610
Address	30-1 Oyaguchikami-machi, Itabashi-ku, Tokyo
TEL	+81-3-3972-8111
Homepage URL
Email	yoshida.nao@nihon-u.ac.jp

Sponsor
Institute	Nihon University School of Medicine
Institute
Department

Funding Source
Organization	None
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	Nihon University Itabashi Hospital
Address	30-1 Oyaguchikami-machi, Itabashi-ku, Tokyo
Tel	+81-3-3972-8111
Email	+81-3-3972-8111

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	2022 Year 04 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	235
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	2014 Year 12 Month 01 Day
Date of IRB	2019 Year 02 Month 01 Day
Anticipated trial start date	2015 Year 01 Month 01 Day
Last follow-up date	2021 Year 12 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	2022 Year 04 Month 01 Day
Last modified on	2022 Year 10 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054018