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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037494
Receipt No. R000042584
Scientific Title The efficacy of ultrasound guided fine-needle biopsy using the clip-with-thread method for small gastric subepithelial lesions-Randomized controlled trial
Date of disclosure of the study information 2019/07/25
Last modified on 2019/10/18

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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
2019 Year 10 Month 18 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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