UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of contrast-enhanced harmonic endoscopic ultrasonography guided fine needle aspiration(EUS-FNA)of pancreatic tumor: a prospective single center study.
Title of the study (Brief title)	Evaluation of contrast-enhanced harmonic endoscopic ultrasonography guided fine needle aspiration(EUS-FNA)of pancreatic tumor
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficancy of contrast enhanced harmonic EUS-FNA prospectively in diagnosimg pancreatic lesions.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	accuracy
Key secondary outcomes	appropriate sampling rate

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	contrast-enhanced harmonic EUS-FNA
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 tumor cases with pancreatic mass requiring EUS-FNA # Written informed consent
Key exclusion criteria	# inability to perform endoscopy # Performance status=4 # Failure of other organs # inability to obtain informed consent # allergy of contrast agent
Target sample size	82

Research contact person
Name of lead principal investigator	Masayuki Kitano
Organization	Wakayama Medical University
Division name	Second Department of Internal Medicine
Address	811-1 Kimiidera Wakayama
TEL	073-447-2300
Email	kitano@wakayama-med.ac.jp

Public contact
Name of contact person	Masahiro Itonaga
Organization	Wakayama Medical University
Division name	Second Department of Internal Medicine
Address	811-1 Kimiidera Wakayama
TEL	073-447-2300
Homepage URL
Email	itonaga@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 01 Day
Anticipated trial start date	2016 Year 10 Month 05 Day
Last follow-up date	2018 Year 03 Month 30 Day
Date of closure to data entry	2018 Year 03 Month 30 Day
Date trial data considered complete	2018 Year 03 Month 30 Day
Date analysis concluded	2018 Year 03 Month 30 Day

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

Management information
Registered date	2016 Year 10 Month 18 Day
Last modified on	2017 Year 12 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028034