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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044450
Receipt No. R000050485
Scientific Title A randomized controlled trial evaluating the efficacy of Endo Trac in endoscopic submucosal dissection(ESD) for gastric epithelial neoplasia
Date of disclosure of the study information 2021/06/06
Last modified on 2021/06/06

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Basic information
Public title A randomized controlled trial evaluating the efficacy of Endo Trac in endoscopic submucosal dissection(ESD) for gastric epithelial neoplasia
Acronym A randomized controlled trial evaluating the efficacy of Endo Trac in endoscopic submucosal dissection(ESD) for gastric epithelial neoplasia
Scientific Title A randomized controlled trial evaluating the efficacy of Endo Trac in endoscopic submucosal dissection(ESD) for gastric epithelial neoplasia
Scientific Title:Acronym A randomized controlled trial evaluating the efficacy of Endo Trac in endoscopic submucosal dissection(ESD) for gastric epithelial neoplasia
Region
Japan

Condition
Condition Gastric epithelial neoplasia
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To confirm the superiority of efficacy and safety of Endo Trac ESD to conventional ESD for patients with gastric epithelial neoplasia
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes ESD procedure time
Key secondary outcomes 1)ESD procedure time according to the proficiency of the operator(trainee or expert),tumor size ,the location of the lesion, the presence of ulcer findings and institutions
2)Equipping time of Endo Trac
3)Procedure time from starting traction by Endo Trac to complete
4)Clip slip-off rate during Endo Trac ESD ,number of Endo Trac used
5)Conversion rate
6)Traction-related damage rate to specimen
7)Histologic evaluation(en bloc resection rate, curative resection rate, depth of tumor ,size of specimen and tumor)
8)Adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Endo Trac ESD group
Interventions/Control_2 Conventional ESD group
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)over 20 years old
2)gastric epihelial tumor that is ESD-adaptive by endoscopy in accordance with the 2020 ESD/EMR guideline for gastric cancer
3)performance status 0-2
4)obtained written informed consent after appropriate explanation prior to study
Key exclusion criteria 1)tumor suspected of deep submucosal invasion
2)tumor diagnosed as not gastric epithelial tumor pathologically
3)whole invisible tumor
4)tumor crossing the esophagogastric junction or the pylorus ring
5)ESD management of over double tumor
6)history of gastrectomy or reconstructive surgery of the gastric tract
7)easy bleeding
8)using over two antiplatelet or an anticoagulant medication
9)severe disease in other organs by ASA classification over class 4
10)pregnancy
11)any other reasons for ineligibility to investigator judgement


Target sample size 150

Research contact person
Name of lead principal investigator
1st name Mikitaka
Middle name
Last name Iguchi
Organization Wakayama Medical University Hospital
Division name Gastroenterology
Zip code 641-8509
Address 811-1 Kimiidera, Wakayama, Wakayama Prefecture , Japan
TEL 073-447-2300
Email mikitaka@wakayama-med.ac.jp

Public contact
Name of contact person
1st name Jun
Middle name
Last name Kinoshita
Organization Wakayama Medical University Hospital
Division name Gastroenterology
Zip code 641-8509
Address 811-1 Kimiidera, Wakayama, Wakayama Prefecture , Japan
TEL 073-447-2300
Homepage URL
Email jun@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization Wakayama Medical University
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Wakayama Medical University Hospital
Address 811-1 Kimiidera, Wakayama, Wakayama Prefecture , Japan
Tel 073-447-2300
Email jun@wakayama-med.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 和歌山県立医科大学附属病院
和歌山ろうさい病院

Other administrative information
Date of disclosure of the study information
2021 Year 06 Month 06 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
2021 Year 04 Month 26 Day
Date of IRB
2020 Year 04 Month 26 Day
Anticipated trial start date
2021 Year 06 Month 06 Day
Last follow-up date
2025 Year 07 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 06 Month 06 Day
Last modified on
2021 Year 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050485

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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