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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001054
Receipt No. R000001262
Scientific Title Intraoperative Freehand Real-time Elastography for Small Focal Liver Lesions
Date of disclosure of the study information 2008/03/01
Last modified on 2010/02/15

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Basic information
Public title Intraoperative Freehand Real-time Elastography for Small Focal Liver Lesions
Acronym Elastography for Small Focal Liver Lesions
Scientific Title Intraoperative Freehand Real-time Elastography for Small Focal Liver Lesions
Scientific Title:Acronym Elastography for Small Focal Liver Lesions
Region
Japan

Condition
Condition Forcal liver lesions to be resected.
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the usefulness of newly developped elastography system applied intraoperatively to liver tumors.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The diagnostic ability of small liver lesions with EI is analyzed with ROC analysis.
Key secondary outcomes The evaluation of specific patterns in which B mode ultrasonography has difficulty in detection.

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 Patients who are scheduled to undergo hepatectomy at our institution, provide a written informed consent, and do not meet the below exclusion criteria.
Key exclusion criteria 1) the preoperative lesion size was more than 2.5 cm in maximum diameter
2) the lesion center was located deeper than 4 cm from the liver surface,
3) the lesion was protruded from the liver surface
4) emergent surgery was required.
Target sample size 30

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

Public contact
Name of contact person
1st name
Middle name
Last name Yosuke Inoue
Organization University of Tokyo, Tokyo University Hospital
Division name Hepato-Biliary-Pancreatic Surgery Division, The Artificial Organ and Transplantation Division, Depar
Zip code
Address
TEL
Homepage URL
Email sukeyaubj@yahoo.co.jp

Sponsor
Institute Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, Tokyo University 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

Other administrative information
Date of disclosure of the study information
2008 Year 03 Month 01 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
2006 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 11 Month 01 Day
Last follow-up date
2008 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2008 Year 08 Month 01 Day

Other
Other related information Twenty-three patients were recruited between November 2006 and July 2007, and EI images of 37 small focal liver lesions (16 metastatic adenocarcinomas, 13 hepatocellular carcinomas, and 8 benign lesions) were obtained after conventional B-mode intraoperative ultrasonography (IOUS). Real-time freehand EI images were obtained for all the lesions except for one metastatic cancer located in the dorsal area of the left lateral segment. All metastatic lesions were depicted as being harder than the background liver, while the hepatocellular carcinomas were expressed with various stiffness. Clear images of 10 lesions were difficult to obtain using conventional B-mode IOUS, whereas EI visualized the differences in elasticity more clearly.

Management information
Registered date
2008 Year 02 Month 26 Day
Last modified on
2010 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001262

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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