UMIN-CTR Clinical Trial

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

Condition
Condition	solid pancreatic mass lesions and swelling lymph nodes
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is evaluating the efficacy of EUS sonopsy CY by comparing EUS sonopsy CY with 22G EUS-FNAB(EchoTip ProCore)needle.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	The tissue collection rate and accuracy rate in each group.
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	In EUS-FNA, 1st and 3rd puncture using EUS sonopsy CY, 2nd and 4th puncture using 22GEUSFNAB needle(EchoTip Procore).
Interventions/Control_2	In EUS-FNA, 1st and 3rd puncture using 22GEUSFNAB needle(EchoTip Procore), 2nd and 4th puncture using EUS sonopsy CY.
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 or swelling lymph node who are refered to EUS-FNA
Key exclusion criteria	1.Performance Status (PS)4. 2.The patient who has serious disease. 3.The pacient with anticoagulant therapy. 4.The woman becomes pregnant or might be pregnant. 5.Insertion of the endoscope is impossible. 6.The patient was judged the physician to be inappropriate.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Atsushi IRISAWA
Organization	Fukushima Medical University Aizu Medical Center
Division name	gastroenterology
Zip code
Address	21-2 Maeda,Tanisawa,Kawahigashi, Aizuwakamatsu City
TEL	(0242)75-2100
Email	irisawa@fmu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Ryo IGARASHI
Organization	Fukushima Medical University Aizu Medical Center
Division name	gastroenterology
Zip code
Address	21-2 Maeda,Tanisawa,Kawahigashi, Aizuwakamatsu City
TEL	(0242)75-2100
Homepage URL
Email	ryo-i@fmu.ac.jp

Sponsor
Institute	Fukushima Medical University Aizu Medical Center
Institute
Department

Funding Source
Organization	Fukushima Medical University Aizu Medical Center
Organization
Division
Category of Funding Organization	Self funding
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 04 Month 05 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	2015 Year 05 Month 01 Day
Date of IRB	2015 Year 05 Month 01 Day
Anticipated trial start date	2015 Year 05 Month 01 Day
Last follow-up date	2020 Year 03 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 04 Month 05 Day
Last modified on	2020 Year 10 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025118