UMIN-CTR Clinical Trial

Basic information
Public title	Diagnostic accuracy of contrast enhanced endoscopic ultrasonography in pancreatbiliary disease
Acronym	A clinical trial of contrast enhanced endoscopic ultrasonography in the pancreatobiliary disease
Scientific Title	Diagnostic accuracy of contrast enhanced endoscopic ultrasonography in pancreatbiliary disease
Scientific Title:Acronym	A clinical trial of contrast enhanced endoscopic ultrasonography in the pancreatobiliary disease
Region	Japan

Condition
Condition	Pancreas tumor, Chronic pancreatitis, Autoimmune pancreatitis, Gallblader polyp, Biliary tract tumor
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of the present study is to evaluate whether contrast-enhanced endoscopic ultrasonography can provide a reliable diagnosis for pancreatobbiliary disease.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To evaluate whether contrast enhanced endoscopic ultrasonography can provide a reliable diagnosis for pancreatobbiliary disease, we compare the diagnostic accuracy of contrast enhanced endoscopic ultrasonography with enhanced conputed tomography, magnetic resonance imaging, and endoscopic ultrasonography without perflubutane
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	Contrast enhanced endoscopic ultrasonography using perflubutane
Interventions/Control_2	MRI
Interventions/Control_3	enhanced CT
Interventions/Control_4	endoscopic ultrasonography without perflubutane
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Patients who are suspected pacreatobiliary disease by ohter modality(CT, US, MRI). 2.Performance status; 0,1,2. 3.Patients who got ingormed consent.
Key exclusion criteria	1.Patients with allergy to egg. 2.Patients with arteriovenous shunt in cardia. 3.Patients woth severe cardiac disease. 4.Patients with sebere lung disorder. 5.Female patients with pregnacy or nursing. 6.Patients with mental aliments who cannot sign up for this clinical trial. 7.Patients with adverse events to perflubutane including minimal side effects. 8.Inadequate patients to participate in this study, in the judgement of an attending doctor or inspection physician.
Target sample size	786

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuki Sumiyama
Organization	The Jikei University School of Medicine
Division name	Department of Endoscopy
Zip code
Address	3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo, Japan
TEL	0334331111
Email	kaz_sum@jikei.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Masafumi Chiba
Organization	The Jikei University School of Medicine
Division name	Department of Endoscopy
Zip code
Address	3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo, Japan
TEL	0334331111
Homepage URL
Email	ccl09720@gmail.com

Sponsor
Institute	Department of Endoscopy The Jikei University School of Medicine
Institute
Department

Funding Source
Organization	Department of Endoscopy The Jikei University School of Medicine
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	東京慈恵会医科大学附属病院（東京都）、東京慈恵会医科大学附属柏病院（千葉県）、東京慈恵会医科大学葛飾医療センター（東京都）、東京慈恵会医科大学附属第三病院（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 01 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	Completed
Date of protocol fixation	2017 Year 11 Month 14 Day
Date of IRB	2018 Year 11 Month 14 Day
Anticipated trial start date	2018 Year 01 Month 15 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	2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 01 Month 09 Day
Last modified on	2019 Year 07 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034581