UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001054 |
|---|---|
| Receipt number | 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 13:40:22 |
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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
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
sukeyaubj@yahoo.co.jp
Sponsor or person
Institute
Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, Tokyo University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001262
