UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective evaluation of 20G core needle for EUS-guided histology of pancreatic tumor
Title of the study (Brief title)	Prospective evaluation of 20G core needle for EUS-guided histology of pancreatic tumor
Region	Japan

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

Objectives
Narrative objectives1	To assess the quality of histological specimen obtained by 20G core needle
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Quality of histology
Key secondary outcomes	The accuracy rate of histology and cytology, The success rate of EUS-FNA, Feasibility of immunohistochemical analysis, the incidence of adverse events

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) Pancreatic tumor in size >10mm 2) age >20
Key exclusion criteria	1) Performance status 4 2) Pregnant woman 3) Platelet count <50,000/mm3 4) PT-international normalized ratio >1.5 or
Target sample size	50

Research contact person
Name of lead principal investigator	Hirotoshi Ishiwatari
Organization	Shizuoka Cancer Center
Division name	Division of Endoscopy
Address	1007 Shimonagakubo Nagaizumicho Suntogun Shizuoka
TEL	055-989-5222
Email	ishihiro481019@gmail.com

Public contact
Name of contact person	Hirotoshi Ishiwatari
Organization	Shizuoka Cancer Center
Division name	Division of Endoscopy
Address	1007 Shimonagakubo Nagaizumicho Suntogun Shizuoka
TEL	055-989-5222
Homepage URL
Email	ishihiro481019@gmail.com

Sponsor
Institute	Division of Endoscopy, Shizuoka Cancer Center
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

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 22 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 06 Month 02 Day
Anticipated trial start date	2016 Year 06 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	Published
URL releasing results
Results
Other related information	none

Management information
Registered date	2016 Year 06 Month 21 Day
Last modified on	2018 Year 12 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026196