UMIN-CTR Clinical Trial

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
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Interventions/Control_6
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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
Email	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
Email	ttoda1231@gmail.com

Sponsor
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

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
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	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
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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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028579