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

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 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


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

Value
https://center6.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