UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to evaluate the usefulness of contrast medium 'Sonazoid; Perflubutane' in EUS diagnosis for pancreaticobiliary tumors.
Title of the study (Brief title)	Usefulness of contrast medium Sonazoid in EUS diagnosis for pancreaticobiliary tumors.
Region	Japan

Condition
Condition	pancreaticobiliary neoplastic lesions that require EUS
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the usefulness of contrast medium 'Sonazoid; Perflubutane' in EUS diagnosis for pancreaticobiliary tumors.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	final diagnostic performance, pathological diagnostic accuracy
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	Sonazoid;Perflubutane suspension 0.015ml/kg
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	Patients with pancreaticobiliary neoplastic lesions that require EUS.
Key exclusion criteria	Cases under 20 years old Cases without written informed consent Cases with allergy for Sonazoid; Perflubutane Cases with possibility of pregnant Cases considered ineligible for this study
Target sample size	100

Research contact person
Name of lead principal investigator	Makoto Takaoka
Organization	Kansai Medical University Hirakata Hospital
Division name	Div. of Gastroenterology and Hepatology, Dept. of Internal Medicine.
Address	5-1, Shinmachi 2-chome, Hirakata city, Osaka pref 573-1191, Japan
TEL	072-804-0101
Email	takaokam@hirakata.kmu.ac.jp

Public contact
Name of contact person	Makoto Takaoka
Organization	Kansai Medical University
Division name	Div. of Gastroenterology and Hepatology, Dept. of Internal Medicine.
Address	5-1, Shinmachi 2-chome, Hirakata city, Osaka pref 573-1191, Japan
TEL	072-804-0101
Homepage URL
Email	kenkyu@hirakata.kmu.ac.jp

Sponsor
Institute	Div. of Gastroenterology and Hepatology, Dept. of Internal Medicine. Kansai Medical University Hirakata Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	None
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

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 04 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 08 Month 12 Day
Anticipated trial start date	2016 Year 01 Month 05 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	2015 Year 12 Month 29 Day
Last modified on	2019 Year 01 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023556