UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	EUS-guided cutting biopsy using forward-viewing echoendoscope in the diagnosis of gastrointestinal subepithelial tumors
Title of the study (Brief title)	Cutting biopsy using forward-viewing echoendoscope
Region	Japan

Condition
Condition	gastrointestinal subepithelial tumor
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate feasibility and safety of the cutting biopsy using forward-viewing echoendoscope
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	diagnostic yield
Key secondary outcomes	procedure time, sample size of spicemen, complication

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	Mucosa and submucosa are cut using needle knife or hot biopsy. Biopsy is taken with biopsy forceps using forward-viewing echoendoscope. Wound is closed using endoclip.
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	gastrointestinal subepithelial lesion, more than 1.5cm in tumor size
Key exclusion criteria	Cases with severe complications and lack of patients consent are excluded.
Target sample size	30

Research contact person
Name of lead principal investigator	Hidemi Goto
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	65, Tsuruma-cho, Showa-ku, Nagoya
TEL	052-744-2172
Email	hgoto@med.nagoya-u.ac.jp

Public contact
Name of contact person	Ippei Matsuzaki
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	65, Tsuruma-cho, Showa-ku, Nagoya
TEL	052-744-2172
Homepage URL
Email	imatsu@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine, Department of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization	Nagoya University Graduate School of Medicine, Department of Gastroenterology and Hepatology
Organization
Division
Category of Funding Organization	Self funding
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	2014 Year 11 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 10 Month 20 Day
Anticipated trial start date	2015 Year 01 Month 01 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

Management information
Registered date	2014 Year 10 Month 07 Day
Last modified on	2017 Year 10 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017797