UMIN-CTR Clinical Trial

Basic information
Public title	A prospective multicenter study of EUS-guided through-the-needle biopsy (EUS-TTNB) for abdominal solid lesion
Acronym	EUS-TTNB
Scientific Title	A prospective multicenter study of EUS-guided through-the-needle biopsy (EUS-TTNB) for abdominal solid lesion
Scientific Title:Acronym	EUS-TTNB
Region	Japan

Condition
Condition	Patients who will undergo EUS-FNA for an abdominal solid lesion
Classification by specialty	Hepato-biliary-pancreatic medicine Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate safety and efficacy of EUS-TTNB
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The diagnostic yield of malignancy (EUS-TTNB, EUS-FNA, EUS-TTNB+EUS-FNA)
Key secondary outcomes	Technical success, safety, rate of macroscopic tissue sampling, the diagnostic yield of specific diseases

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	EUS-guided through-the-needle biopsy
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients with abdominal solid lesion 15mm amd larger who will undergo EUS-FNA 2)Age 20 years and older 3)ECOG PS 0-3 4)written informed consent
Key exclusion criteria	1)Patients with coagulopathy 2)Patients whose lesions are not safely punctured by EUS-FNA 3)No informed consent 4)Patients who are considered as inappropriate for study enrollment by investigators
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroyuki Isayama
Organization	The University of Tokyo, Graduate School of Medicine
Division name	Department of Gastroenterology
Zip code
Address	7-3-1, Hongo, Bunkyo-ku Tokyo
TEL	03-3815-5411
Email	isayama-tky@umin.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yousuke Nakai
Organization	The University of Tokyo, Graduate School of Medicine
Division name	Department of Gastroenterology
Zip code
Address	7-3-1, Hongo, Bunkyo-ku Tokyo
TEL	03-3815-5411
Homepage URL
Email	ynakai-tky@umin.ac.jp

Sponsor
Institute	The University of Tokyo
Institute
Department

Funding Source
Organization	None
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	東京大学医学部付属病院(東京都), 岐阜大学附属病院(岐阜県), 岐阜市民病院(岐阜県), 東京警察病院(東京都), 日本赤十字社医療センター(東京都), 関東中央病院(東京都)

Other administrative information
Date of disclosure of the study information	2014 Year 06 Month 03 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	Terminated
Date of protocol fixation	2014 Year 05 Month 09 Day
Date of IRB
Anticipated trial start date	2014 Year 06 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 06 Month 03 Day
Last modified on	2017 Year 05 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016478

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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