UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Prospective Cohort Study on the usefulness of contrast-enhanced harmonic endoscopic ultrasonography (CH-EUS) in differential diagnosis of Pancreatic tumors.
Title of the study (Brief title)	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	Hironari Kato
Organization	Okayama university hospital
Division name	Gastroenterology and hepatology
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	Naoki Yamamoto
Organization	Okayama university hospital
Division name	Gastroenterology and hepatology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 12 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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