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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034970
Receipt No. R000039874
Scientific Title Prospective study on the effectiveness and safety of endoscopic resection using Souten snare in gastric tumors
Date of disclosure of the study information 2018/11/21
Last modified on 2019/05/13

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Basic information
Public title Prospective study on the effectiveness and safety of endoscopic resection using Souten snare in gastric tumors
Acronym Efficacy of endoscopic resection using Souten snare in stomach tumor
Scientific Title Prospective study on the effectiveness and safety of endoscopic resection using Souten snare in gastric tumors
Scientific Title:Acronym Efficacy of endoscopic resection using Souten snare in stomach tumor
Region
Japan

Condition
Condition gastric tumor
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to assess the efficacy and safety of Souten snare in hybrid ESD of gastric tumor prospectively.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes procedure time, histological complete resection rate, curative resection rate, perforation rate, bleeding rate
Key secondary outcomes required medical expenses

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 Differentiated mucosal carcinoma without ulcer at 15mm or less
Key exclusion criteria Lesions for which surgical resection is desired by preoperative diagnosis
Patients who were judged not eligible for participation in this study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taiga Chiyo
Organization Kagawa University, Faculty of Medicine
Division name Department of Gastroenterology and Neurology
Zip code
Address 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan
TEL +81-87-891-2156
Email t_chiyo@med.kagawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taiga Chiyo
Organization Kagawa University, Faculty of Medicine
Division name Department of Gastroenterology and Neurology
Zip code
Address 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan
TEL +81-87-891-2156
Homepage URL
Email t_chiyo@med.kagawa-u.ac.jp

Sponsor
Institute Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University, Japan
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
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

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 21 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
2018 Year 12 Month 01 Day
Date of IRB
2019 Year 03 Month 29 Day
Anticipated trial start date
2019 Year 03 Month 29 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2018 Year 11 Month 21 Day
Last modified on
2019 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039874

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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