UMIN-CTR Clinical Trial

Basic information
Public title	A prospective randomized cotrolled study comparing EUS sonopsy CY(R) and 22G biopsy needles for EUS-guided fine-needle aspiration of solid pancreatic mass lesions
Acronym	A prospective randomized cotrolled study comparing EUS sonopsy CY(R) and 22G biopsy needles for EUS-guided fine-needle aspiration of solid pancreatic mass lesions
Scientific Title	A prospective randomized cotrolled study comparing EUS sonopsy CY(R) and 22G biopsy needles for EUS-guided fine-needle aspiration of solid pancreatic mass lesions
Scientific Title:Acronym	A prospective randomized cotrolled study comparing EUS sonopsy CY(R) and 22G biopsy needles for EUS-guided fine-needle aspiration of solid pancreatic mass lesions
Region	Japan

Condition
Condition	solid pancreatic mass lesions
Classification by specialty	Hepato-biliary-pancreatic medicine Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is evaluating the efficacy of EUS sonopsy CY(R) by comparing EUS sonopsy CY(R) with 22G EUS-FNA(Sonotip 22G(R))needle by Gerke's Cellularity score.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	The tissue collection rate in each group.
Key secondary outcomes	The tissue collection rate based on the tumor size location and puncture route, the tissue collection rate of all session , the tissue diagnosis rate and adverse event in each group.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	In EUS-FNA, 1st puncture using EUS sonopsy CY(R) and 2nd puncture using 22GEUSFNA needle(Sonotip 22G(R)).
Interventions/Control_2	In EUS-FNA, 1st puncture using 22GEUSFNA needle(Sonotip 22G(R)) and 2nd puncture using EUS sonopsy CY(R).
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	Patients with pancreatic mass who are refered to EUS-FNA
Key exclusion criteria	Patients with Performance status 4 Patients who have risk of bleeding,or patients with platelet count less than fifty thousand/mm2 Patients with antithrombotic agent 2 agent or more Patients with pancreatic mass which we cannot detect by EUS Pregnant woman Patients less than 20 years old Patients who do not agree to participate in this study Patients who determined to be inappropriate
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hironari Kato
Organization	Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name	Department of Gastroenterology and Hepatology
Zip code
Address	2-5-1 Shikata-cho, Okayama, 700-8558, Japan
TEL	086-235-7219
Email	drkatocha@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Sho mizukawa
Organization	Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name	Department of Gastroenterology and Hepatology
Zip code
Address	2-5-1 Shikata-cho, Okayama, 700-8558, Japan
TEL	086-235-7219
Homepage URL
Email	mimizukawa@gmail.com

Sponsor
Institute	Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 01 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	2016 Year 01 Month 19 Day
Date of IRB	2016 Year 01 Month 19 Day
Anticipated trial start date	2016 Year 02 Month 01 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 01 Month 20 Day
Last modified on	2019 Year 09 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023852