UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy of ultrasound guided fine-needle biopsy using the clip-with-thread method for small gastric subepithelial lesions-Randomized controlled trial
Acronym	The efficacy of ultrasound guided fine-needle biopsy using the clip-with-thread method for small gastric subepithelial lesions
Scientific Title	The efficacy of ultrasound guided fine-needle biopsy using the clip-with-thread method for small gastric subepithelial lesions-Randomized controlled trial
Scientific Title:Acronym	The efficacy of ultrasound guided fine-needle biopsy using the clip-with-thread method for small gastric subepithelial lesions
Region	Japan

Condition
Condition	gastric subepithlial lesion
Classification by specialty	Medicine in general Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The efficacy of endoscopic ultrasound guided fine-needle biopsy using the clip-with-thread method
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Success rate of tissue sampling
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	endoscopic ultrasound guided fine-needle biopsy using the clip-with-thread method
Interventions/Control_2	endoscopic ultrasound guided fine-needle biopsy without the clip-with-thread method
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 who are diagnosed SMT and undergo eendoscopic ultrasound guided fine-needle biopsy. 2. Patients from whom written informed consent is obtained. 3. Patients who are older than 20 years old.
Key exclusion criteria	1. Patients who are judged as contraindication for endoscopy. 2. Patients who have metal allergy. 3. Patients who are judged as being inappropriate for this study by their medical doctor. 4. Patients from whom written informed consent is not obtained.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name eikichi Middle name Last name ihara
Organization	Kyushu University
Division name	Department of Medicine and Bioregulatory Science
Zip code	851-8582
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL	+810926425082
Email	eikichi@intmed3.med.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Yosuke Middle name Last name Minoda
Organization	Kyushu university
Division name	Department of Medicine and Bioregulatory Science
Zip code	851-8582
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL	+810926425082
Homepage URL
Email	yminoda@med.kyushu-u.ac.jp

Sponsor
Institute	Kyushu University
Institute
Department

Funding Source
Organization	kyushu University
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	Kyushu university
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
Tel	+810926425082
Email	byskenkyu@jimu.kyushu-u.ac.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	2019 Year 07 Month 25 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	Open public recruiting
Date of protocol fixation	2019 Year 07 Month 15 Day
Date of IRB	2019 Year 08 Month 08 Day
Anticipated trial start date	2019 Year 08 Month 09 Day
Last follow-up date	2024 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 07 Month 25 Day
Last modified on	2020 Year 04 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042584

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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