UMIN-CTR Clinical Trial

Basic information
Public title	A multicenter prospective study for the utility of a target sample check illuminator (TSCI), concerning the detection of target specimens in endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) samples for pancreatic masses and lymph node tumors.
Acronym	A multicenter prospective study for the utility of a target sample check illuminator
Scientific Title	A multicenter prospective study for the utility of a target sample check illuminator (TSCI), concerning the detection of target specimens in endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) samples for pancreatic masses and lymph node tumors.
Scientific Title:Acronym	A multicenter prospective study for the utility of a target sample check illuminator
Region	Japan

Condition
Condition	pancreatic masses and lymph node tumors.
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We will examine the advantage of introducing the use of a TSCI with EUS-FNA for pancreatic masses and lymph node tumors without using ROSE.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The detection rate for target specimens by viewing only.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	We will perform endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for pancreatic masses and lymph node tumors.
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	1) Age of patients at start of the trial is 20 years or older 2) Patients with digestive malignant tumors with the need of pathological diagnosis before treatment
Key exclusion criteria	1) People who have taken chemotheraphy for malignant tumors within one month before the start of the trial. 2) Patients who have had other cancers 3) Patients who are taking anticoagulant or antithrombotic drugs 4) Women who are pregnant or are possibly pregnan
Target sample size	48

Research contact person
Name of lead principal investigator	1st name Kazuya Middle name Last name Matsumoto
Organization	Tottori University School of medicine
Division name	Division of Medicine and Clinical Science
Zip code	6838504
Address	36-1 Nishi-cho, Yonago 683-8504, Japan
TEL	0859-38-6527
Email	ayano0620@hotmail.co.jp

Public contact
Name of contact person	1st name Kazuya Middle name Last name Matsumoto
Organization	Tottori University School of medicine
Division name	Division of Medicine and Clinical Science
Zip code	6838504
Address	36-1 Nishi-cho, Yonago 683-8504, Japan
TEL	0859-38-6527
Homepage URL
Email	ayano0620@hotmail.co.jp

Sponsor
Institute	Tottori University
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	Tottori University Hospital
Address	36-1 Nishi-cho, Yonago 683-8504, Japan
Tel	0859-38-6527
Email	ayano0620@hotmail.co.jp

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 07 Month 27 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	56
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 06 Month 22 Day
Date of IRB	2016 Year 06 Month 22 Day
Anticipated trial start date	2016 Year 07 Month 27 Day
Last follow-up date	2022 Year 08 Month 01 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 07 Month 27 Day
Last modified on	2022 Year 08 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026905