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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000070
Receipt No. 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

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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
Email

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/
Email tateishi-tky@umin.ac.jp

Sponsor
Institute Department of Gastroenterology
University of Tokyo, Graduate School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000117

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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