UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044450 |
|---|---|
| Receipt number | R000050485 |
| Scientific Title | Traction method versus conventional endoscopic submucosal dissection for gastric epithelial neoplasms |
| Date of disclosure of the study information | 2021/06/06 |
| Last modified on | 2024/12/08 16:25:16 |
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Basic information
Public title
Traction method versus conventional endoscopic submucosal dissection for gastric
epithelial neoplasms
Acronym
Traction method versus conventional endoscopic submucosal dissection for gastric
epithelial neoplasms
Scientific Title
Traction method versus conventional endoscopic submucosal dissection for gastric
epithelial neoplasms
Scientific Title:Acronym
Traction method versus conventional endoscopic submucosal dissection for gastric
epithelial neoplasms
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
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
jun@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
150
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
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2021 | 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
| 2024 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050485
