UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000070 |
|---|---|
| Receipt number | R000000117 |
| Scientific Title | A randomized controlled trial of CT angiography prior to percutaneous tumor ablation for hepatocellular carcinoma |
| Date of disclosure of the study information | 2005/09/01 |
| Last modified on | 2012/08/20 09:21:55 |
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Basic information
Public title
A randomized controlled trial of CT angiography prior to percutaneous tumor ablation for hepatocellular carcinoma
Acronym
A randomized controlled trial of CT angiography prior to tumor ablation for HCC
Scientific Title
A randomized controlled trial of CT angiography prior to percutaneous tumor ablation for hepatocellular carcinoma
Scientific Title:Acronym
A randomized controlled trial of CT angiography prior to tumor ablation for HCC
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the usefulness of CT angiography prior to percutaneous tumor ablation for hepatocellular carcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Recurrence free survival after percutaneous tumor ablation for hepatocellular carcinoma
Key secondary outcomes
Newly detected cancer nodules by CT angiography
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
CT angiography prior to percutaneous tumor ablation for hepatocelluar carcinoma
Interventions/Control_2
Percutaneous tumor ablation to hepatocellular carcinoma without CT angiography
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed as typical (hypervascular) hepatocellular carcinoma by dynamic CT
Patients who have no more than 3 hepatocellular carcinoma nodules, each 3cm or less in diameter
Well preserved liver function (Child A)
Key exclusion criteria
Patients who have allergy to contrast media
Patients who have extrahepatic metastasis
Patients with severely impaired renal function
Patients with severe coagulopathy
Target sample size
280
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masao Omata |
Organization
University of Tokyo, Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
7-3-1 Hongo Bukyo-ku Tokyo
TEL
03-3815-5411
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryosuke Tateishi |
Organization
University of Tokyo, Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
7-3-1 Hongo Bunkyo-ku Tokyo
TEL
03-3815-5411
Homepage URL
https://center.umin.ac.jp/islet/ctap/
tateishi-tky@umin.ac.jp
Sponsor or person
Institute
Department of Gastroenterology
University of Tokyo, Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Science, Sports and Culture
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2005 | Year | 09 | 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
Completed
Date of protocol fixation
| 2004 | Year | 03 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2005 | Year | 08 | Month | 20 | Day |
Last modified on
| 2012 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000117
