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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022673
Receipt No. R000026133
Scientific Title A Prospective Cohort Study on the usefulness of contrast-enhanced harmonic endoscopic ultrasonography (CH-EUS) in differential diagnosis of Pancreatic tumors.
Date of disclosure of the study information 2016/06/09
Last modified on 2018/10/02

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Basic information
Public title A Prospective Cohort Study on the usefulness of contrast-enhanced harmonic endoscopic ultrasonography (CH-EUS) in differential diagnosis of Pancreatic tumors.
Acronym Usefulness of contrast-enhanced harmonic endoscopic ultrasonography (CH-EUS)
Scientific Title A Prospective Cohort Study on the usefulness of contrast-enhanced harmonic endoscopic ultrasonography (CH-EUS) in differential diagnosis of Pancreatic tumors.
Scientific Title:Acronym Usefulness of contrast-enhanced harmonic endoscopic ultrasonography (CH-EUS)
Region
Japan

Condition
Condition Pancreatic tumors
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the usefulness of contrast-enhanced harmonic endoscopic ultrasonography (CH-EUS) in differential diagnosis of pancreatic tumors.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes To assess the diagnostic ability of CH-EUS in differential diagnosis of pancreatic tumors.
Key secondary outcomes To compare the diagnostic ability of CH-EUS with that of conventional B-mode EUS and multidetector-row computed tomography (MDCT).
To assess the diagnostic ability of CH-EUS with TIC analysis in differential diagnosis of pancreatic tumors.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 CH-EUS
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 1)Patients depicted Pancreatic mass using conventional EUS.
2)ECOG performance status = 0-1
3)Patients with adequate function of major organs
4)Patients who have provided written informed consent for participation in this study.
Key exclusion criteria 1)The patients who had an allergy to the contrast agent, Sonazoid.
2)The patients who had severe or uncontrolled concomitant systemic disorder.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hironari Kato
Organization Okayama university hospital
Division name Gastroenterology and hepatology
Zip code
Address 2-5-1, Shikata-cho, kita-ku, Okayama
TEL 086-235-7219
Email katou-h@cc.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Yamamoto
Organization Okayama university hospital
Division name Gastroenterology and hepatology
Zip code
Address 2-5-1, Shikata-cho, kita-ku, Okayama
TEL 086-235-7219
Homepage URL
Email Naokihiko@gmail.com

Sponsor
Institute Okayama university hospital Gastroenterology and hepatology
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 岡山大学病院(岡山県)

Other administrative information
Date of disclosure of the study information
2016 Year 06 Month 09 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 Completed
Date of protocol fixation
2011 Year 12 Month 20 Day
Date of IRB
Anticipated trial start date
2011 Year 12 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 06 Month 09 Day
Last modified on
2018 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026133

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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