UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025092 |
|---|---|
| Receipt number | R000028579 |
| Scientific Title | Clinical evaluation of Tissue Elasticity Imaging for intraoperative diagnosis of hepato-billiary-pancreatic disease |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2020/12/03 09:17:28 |
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Basic information
Public title
Clinical evaluation of Tissue Elasticity Imaging for intraoperative diagnosis of hepato-billiary-pancreatic disease
Acronym
Clinical evaluation of Tissue Elasticity Imaging for intraoperative diagnosis of hepato-billiary-pancreatic disease
Scientific Title
Clinical evaluation of Tissue Elasticity Imaging for intraoperative diagnosis of hepato-billiary-pancreatic disease
Scientific Title:Acronym
Clinical evaluation of Tissue Elasticity Imaging for intraoperative diagnosis of hepato-billiary-pancreatic disease
Region
| Japan |
Condition
Condition
hepato-biliary-pancreatic disease
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the efficacy of tissue elasticity imaging at pre- and intraoperative diagnosis of hepato-biliary-pancreatic disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Accuracy of tissue elasticity imaging at the diagnosis of hepato-biliary-pancreatic tumor
Key secondary outcomes
shear wave velocity (Vs value) of liver, pancreas, spleen parenchyma
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
patient undergo hepato-biliary-pancreatic surgery in our facility
Key exclusion criteria
1. Cases hard to examine tissue elasticity imaging for sever adhesion.
2. Emergency cases
3. Cases which operator judge inadequate for examining tissue elasticity imaging
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihiro Kokudo |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Hepato-Biliary-Pancreatic Surgery Division and Artificial Organ and Transplantation Division, Department of Surgery,
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
KOKUDO-2SU@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeo Toda |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery,
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411ext.30359
Homepage URL
ttoda1231@gmail.com
Sponsor or person
Institute
Hepato-Biliary-Pancreatic Surgery Division and Artificial Organ and Transplantation Division, Department of Surgery, Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Fund of Japan Surgical Society
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 12 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
cohort study
Object of this study : Patient who undergo hepato-biliary-pancreatic(HPB) surgery in our institution, without exclusion criteria
Measurement : Elasticity of HPB tumor or parenchyma
Management information
Registered date
| 2016 | Year | 11 | Month | 30 | Day |
Last modified on
| 2020 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028579
