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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000995
Receipt No. R000001198
Scientific Title Is There Any Difference in Survival According to the Portal Thrombectomy Method in Patients with Hepatocellular Carcinoma?
Date of disclosure of the study information 2008/01/26
Last modified on 2008/01/24

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Basic information
Public title Is There Any Difference in Survival According to the Portal Thrombectomy Method in Patients with Hepatocellular Carcinoma?
Acronym PVTT thrombectomy comparison
Scientific Title Is There Any Difference in Survival According to the Portal Thrombectomy Method in Patients with Hepatocellular Carcinoma?
Scientific Title:Acronym PVTT thrombectomy comparison
Region
Japan

Condition
Condition Resactable hepatocellular carcinoma (HCC) with macroscopic portal venous thrombus (PVTT)
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To describe and evaluate the surgical resection of portal venous tumor thrombi (PVTT) using a method in which the venous wall is peeled off from the PVTT.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes overall survival and recurrence-free survival
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients who have HCC with PVTT macroscopically detected with preoperative imaging modalities.
Key exclusion criteria The patients who failed to reap the curative operation.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihiro Kokudo
Organization Tokyo University Hospital
Division name Hepato-Biliary-Pancreatic Surgery Division
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yosuke Inoue
Organization Tokyo University Hospital
Division name Hepato-Biliary-Pancreatic Surgery Division
Zip code
Address
TEL
Homepage URL
Email sukeyaubj@yahoo.co.jp

Sponsor
Institute Hepato-Biliary-Pancreatic Surgery Division, Tokyo University Hospital
Institute
Department

Funding Source
Organization The Kanae Foundation for Life & Socio-medical Science
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
Address
Tel
Email

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
2008 Year 01 Month 26 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 Completed
Date of protocol fixation
1995 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
1995 Year 01 Month 01 Day
Last follow-up date
2007 Year 08 Month 01 Day
Date of closure to data entry
2007 Year 08 Month 01 Day
Date trial data considered complete
2007 Year 08 Month 01 Day
Date analysis concluded
2007 Year 11 Month 01 Day

Other
Other related information The short-term results including the amount of intraoperative bleeding, operation duration, the incidence of blood transfusion, postoperative morbidity, and mortality, and the long-term results including the overall survival and recurrence-free survival were reviewed and compared between the two groups.

Management information
Registered date
2008 Year 01 Month 24 Day
Last modified on
2008 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001198

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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