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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003046
Receipt No. R000003695
Scientific Title Utility of contrast enhanced intraoperative ultrasound using Sonazoid for patients with hepatocellular carcinoma
Date of disclosure of the study information 2010/01/16
Last modified on 2011/02/05

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Basic information
Public title Utility of contrast enhanced intraoperative ultrasound using Sonazoid for patients with hepatocellular carcinoma
Acronym Contrast enhanced intraoperative ultrasound using Sonazoid for hepatocellular carcinoma
Scientific Title Utility of contrast enhanced intraoperative ultrasound using Sonazoid for patients with hepatocellular carcinoma
Scientific Title:Acronym Contrast enhanced intraoperative ultrasound using Sonazoid for hepatocellular carcinoma
Region
Japan

Condition
Condition hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the ability of contrast enhanced intraoperative ultrasoud using Sonazoid to detect, diagnose, and resect new hepatocellular carcinomas which have not been diagnosed during the preoperative imaging study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Diagnostic ability to differentiate new lesions detected during conventional fundamental intraoperative ultrasound.
2. Frequency to find new hepatocellular carcinoma solely by contrast enhanced intraoperative ultrasound.
Key secondary outcomes Safety of contrast enhanced intraoperative ultrasound using Sonazoid.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Contrast enhanced intraoperative ultrasound using Sonazoid
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 Patients undergoing surgery for hepatocellular carcinoma
Key exclusion criteria 1. Cardiac failure
2. Allergy against egg
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihiro Kokudo
Organization University of Tokyo Hospital
Division name Hepato-Biliary-Pancreatic Surgery Division and Artificial Organ and Transplantation Division
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL +81-3-5800-8655
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization University of Tokyo Hospital
Division name Hepato-Biliary-Pancreatic Surgery Division and Artificial Organ and Transplantation Division
Zip code
Address 7-3-1, Bunkyo-Ku, Hongo, Tokyo, 113-8655, Japan
TEL
Homepage URL
Email

Sponsor
Institute Hepato-Biliary-Pancreatic Surgery Division and Artificial Organ and Transplantation Division, University of Tokyo Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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 東京大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 16 Day

Related information
URL releasing protocol
Publication of results Published

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
2008 Year 07 Month 07 Day
Date of IRB
Anticipated trial start date
2008 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2010 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 01 Month 16 Day
Last modified on
2011 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003695

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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