UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and efficacy of endoscopic ultrasound guided fine needle aspiration with core biopsy needle for pancreatic mass: A prospective study
Title of the study (Brief title)	ProCore Study for Pancreatic Mass
Region	Japan

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

Objectives
Narrative objectives1	to evaluate the novel FNB needle with forward bevel
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	accurate histological diagnosis
Key secondary outcomes

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	100 years-old >
Gender	Male and Female
Key inclusion criteria	patients with a solid pancreatic mass larger than 15 mm which required EUS-FNA for pathological confirmation
Key exclusion criteria	(1) difficulty in endoscopic approach due to prior gastroduodenal surgery, (2) daily use of anti-coagulant medicine, (3) platelet count of less than 50,000mm3, (4) PT-INR of more than 1.5.
Target sample size	70

Research contact person
Name of lead principal investigator	Naoki Sasahira
Organization	The Cancer Institute Hospital of JFCR
Division name	Department of Gastroenterology
Address	3-8-31, Ariake, Koto-Ku, Tokyo
TEL	03-3520-0111
Email	naoki.sasahira@jfcr.or.jp

Public contact
Name of contact person	Ryo Kanata
Organization	The Cancer Institute Hospital of JFCR
Division name	Department of Gastroenterology
Address	3-8-31, Ariake, Koto-Ku, Tokyo
TEL	03-3520-0111
Homepage URL
Email	ryo.kanata@jfcr.or.jp

Sponsor
Institute	Japanese Foundation for Cancer Research
Institute
Department

Funding Source
Organization	Self
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	2017 Year 01 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 15 Day
Anticipated trial start date	2017 Year 01 Month 25 Day
Last follow-up date	2018 Year 04 Month 25 Day
Date of closure to data entry	2018 Year 04 Month 25 Day
Date trial data considered complete	2018 Year 05 Month 25 Day
Date analysis concluded	2018 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	NON

Management information
Registered date	2017 Year 01 Month 19 Day
Last modified on	2018 Year 08 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029614