UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000995 |
|---|---|
| Receipt number | 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 14:29:15 |
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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
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
sukeyaubj@yahoo.co.jp
Sponsor or person
Institute
Hepato-Biliary-Pancreatic Surgery Division, Tokyo University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001198
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
