UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047362 |
|---|---|
| Receipt number | R000054018 |
| Scientific Title | Study of liver surgical anatomy using 3D simulation software |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2022/10/03 06:19:58 |
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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
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
yoshida.nao@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
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
+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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054018
