UMIN-CTR Clinical Trial

Basic information
Public title	Diagnostic value of EUS elastography and shear wave elastography for pancreatic solid masses
Acronym	Usefulness of EUS elastography and shear wave elastography for pancreatic diseases
Scientific Title	Diagnostic value of EUS elastography and shear wave elastography for pancreatic solid masses
Scientific Title:Acronym	Usefulness of EUS elastography and shear wave elastography for pancreatic diseases
Region	Japan

Condition
Condition	pancreatic solid masse
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Diagnostic performance of EUS elastography and shear wave elastography for pancreatic cancer and Comparison of the measurements of non-tumor lesion in each elastography.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Diagnostic performance of EUS elastography and shear wave elastography for pancreatic cancer confirmed by pathological examination.
Key secondary outcomes	1 Relation between the measurements of each elastography and clinical features including pathological examination. 2. Relation between the measurements of each elastography and radiological examinations including CT and MRI. 3. Relation between the measurements of each elastography and effect of chemotherapy. 4. Comparison of the measurements of each elastography between non-tumor lesion of pancreatic cancer and control.

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patinets with pancreatic mass lesion and patients with non-pancreatic disease for control. Patinets with written informed consent.
Key exclusion criteria	Patinets without written infromed consent. Patinets considered ineligible for this study.
Target sample size	150

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Rintaro Mikata
Organization	Chiba University Hospital
Division name	Department of Gastroenterology
Zip code
Address	1-8-1 Inohana, Chuo Ward, Chiba 260-8670, Japan
TEL	81-43-222-7171
Email	mikata@faculty.chiba-u.jp

Public contact
1st name of contact person	1st name Middle name Last name Rintaro Mikata
Organization	Chiba University Hospital
Division name	Department of Gastroenterology
Zip code
Address	1-8-1 Inohana, Chuo Ward, Chiba 260-8670, Japan
TEL	81-43-222-7171
Homepage URL
Email	mikata@faculty.chiba-u.jp

Sponsor
Institute	Chiba University Hospital
Institute
Department

Funding Source
Organization	Chiba University Hospital
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	2018 Year 10 Month 15 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	No longer recruiting
Date of protocol fixation	2017 Year 11 Month 01 Day
Date of IRB	2018 Year 11 Month 20 Day
Anticipated trial start date	2018 Year 12 Month 04 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information	Nothing paticular

Management information
Registered date	2018 Year 10 Month 15 Day
Last modified on	2019 Year 05 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039329