UMIN-CTR Clinical Trial

Basic information
Public title	Utility of contrast-enhanced harmonic endoscopic ultrasonography for diagnosis of pancreatic tumors: a prospective multicenter study
Acronym	Utility of contrast-enhanced harmonic endoscopic ultrasonography
Scientific Title	Utility of contrast-enhanced harmonic endoscopic ultrasonography for diagnosis of pancreatic tumors: a prospective multicenter study
Scientific Title:Acronym	Utility of contrast-enhanced harmonic endoscopic ultrasonography
Region	Japan

Condition
Condition	Pancreatic tumors
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 the diagnostic accuracy of contrast-enhanced harmonic endoscopic ultrasonography for pancreatic tumors by comparing with the other modalities. A multicenter cohort study.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To measure the diagnostic ability of contrast-enhanced harmonic endoscopic ultrasonography in diagnosing pancreatic tumors. To compare the diagnostic accuracy of contrast-enhanced harmonic endoscopic ultrasonography with that of tissue harmonic endoscopic ultrasonography.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Contrast-enhanced harmonic endoscopic ultrasonography
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	Pancreatic mass of 3cm or less to be depicted by conventional endoscopic ultrasonography Written informed consent ECOG performance status = 0-2
Key exclusion criteria	Inapropriate to perform endoscopic ultrasonography Impossible to perform endoscopy Surgically altered digestive tract Failure of other organs (ASA: Grade 3, 4) Allergy to iodine or eggs Renal failure Inability to obtain informed consent
Target sample size	240

Research contact person
Name of lead principal investigator	1st name Kitano Middle name Last name Masayuki
Organization	Wakayama Medical University
Division name	Second Department of Internal Medicine
Zip code	641-8509
Address	811-1 Kimiidera, Wakayama
TEL	073-441-0627
Email	kitano@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Shunsuke Middle name Last name Omoto
Organization	Kindai University Faculty of Medicine
Division name	gastroenterology and hepatology
Zip code	589-8511
Address	377-2 Ohno-higashi, Osaka-sayama, Osaka, JAPAN
TEL	072-366-0221
Homepage URL
Email	shunsuke.oomoto@gmail.com

Sponsor
Institute	Study Group for Contrast-enhanced Harmonic Endoscopic Ultrasonography
Institute
Department

Funding Source
Organization	The Japanese Foundation for Research and Promotion of Endoscopy
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kindai University Faculty of Medicine Clinical Research Center
Address	377-2 Ohno-higashi, Osaka-sayama, Osaka, JAPAN
Tel	072-366-0221
Email	zizen@med.kindai.ac.jp

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	東北大学医学部附属病院（宮城県）、横浜市立大学総合医療センター（神奈川県）、山梨大学医学部附属病院（山梨県）、大阪府立成人病センター（大阪府）、近畿大学医学部附属病院（大阪府）、神戸大学医学部附属病院（兵庫県）、岡山大学医学部附属病院（岡山県）

Other administrative information
Date of disclosure of the study information	2013 Year 07 Month 20 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	2013 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date	2013 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry	2014 Year 11 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 07 Month 05 Day
Last modified on	2020 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013035