UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter prospective registration study evaluating diagnostic yield of the 22G Franseen needle in patients undergoing EUS-guided tissue acquisition of pancreatic solid lesions
Title of the study (Brief title)	Multicenter prospective registration study evaluating EUS-FNA using the 22G Franseen needle
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the diagnostic yield of EUS-FNB using the 22G Franseen needle in patients with pancreatic solid lesions
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Diagnostic accuracy of EUS-FNB using the 22G Franseen needle
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Patients who are over 20 years old. 2)Patients with pancreatic solid tumors. 3)Patients who need histopathological diagnosis for pancreatic neoplasms by EUS-FNB. 4)Patients who provided written informed consent.
Key exclusion criteria	1)Patients who are not applicable to endoscopy and EUS-FNB. 2)Patients who judged as inappropriate by attendant doctor. 3)Patients who rejected participating in this study.
Target sample size	235

Research contact person
Name of lead principal investigator	Yousuke Nakai
Organization	Tokyo University
Division name	Department of Gastroenterology
Address	7-3-1 Hongo Bunkyo-ku, Tokyo, Japan 113-8655
TEL	03-3815-5411
Email	ynakai-tky@umin.ac.jp

Public contact
Name of contact person	Kazunaga Ishigaki
Organization	Tokyo University
Division name	Department of Gastroenterology
Address	7-3-1 Hongo Bunkyo-ku, Tokyo, Japan 113-8655
TEL	03-3815-5411
Homepage URL
Email	ishigakikazunaga@gmail.com

Sponsor
Institute	Tokyo University
Institute
Department

Funding Source
Organization	Tokyo University
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	2018 Year 07 Month 30 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 07 Month 17 Day
Anticipated trial start date	2018 Year 07 Month 30 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	Unpublished
URL releasing results
Results
Other related information	Data of EUS-FNB using the 22G Franseen needle

Management information
Registered date	2018 Year 07 Month 27 Day
Last modified on	2018 Year 07 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038232