UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045461 |
|---|---|
| Receipt number | R000051906 |
| Scientific Title | A randomized controlled trial comparing conventional ESD versus multi-traction ESD for gastric lesions in porcine mode |
| Date of disclosure of the study information | 2021/09/15 |
| Last modified on | 2023/05/21 22:41:54 |
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Basic information
Public title
A randomized controlled trial comparing conventional ESD versus multi-traction ESD for gastric lesions in porcine mode
Acronym
MULTI-trial
Scientific Title
A randomized controlled trial comparing conventional ESD versus multi-traction ESD for gastric lesions in porcine mode
Scientific Title:Acronym
MULTI-trial
Region
| Japan |
Condition
Condition
gastric lesions
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the efficacy of multi-traction ESD
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ESD procedure time
Key secondary outcomes
Time and speed of mucosal incision and submucosal dissection, arrangement time for traction, en boc/complete resection rate, the volume of submucosal injection, operator change, the number of traction devices and clips, predictive factors associated with ESD difficulties
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 not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Standard treatment group (Group A): conventional ESD
Interventions/Control_2
Study treatment group (Group B): Multi traction ESD (MT-ESD)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Simulated lesions created in the porcine stomach model
(2)Leasions larger than 30mm
Key exclusion criteria
Lesions contiguous to the pylorus or fossa
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Mitsuru |
| Middle name | |
| Last name | Esaki |
Organization
Kyushu University
Division name
Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka City
TEL
+81926425286
esaki_saiseikai@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Mitsuru |
| Middle name | |
| Last name | Esaki |
Organization
Kyushu University
Division name
Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka City
TEL
+81926425286
Homepage URL
esaki_saiseikai@yahoo.co.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
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
Tel
+81926425286
esaki_saiseikai@yahoo.co.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
| 2021 | Year | 09 | Month | 15 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 12 | Day |
Last modified on
| 2023 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051906
