UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044343 |
|---|---|
| Receipt number | R000050615 |
| Scientific Title | A randomized controlled trial comparing conventional ESD versus ProKnife ESD with injective function for gastric lesions in porcine models |
| Date of disclosure of the study information | 2021/05/28 |
| Last modified on | 2022/05/28 11:12:29 |
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Basic information
Public title
A randomized controlled trial comparing conventional ESD versus ProKnife ESD with injective function for gastric lesions in porcine models
Acronym
P-ESD trial
Scientific Title
A randomized controlled trial comparing conventional ESD versus ProKnife ESD with injective function for gastric lesions in porcine models
Scientific Title:Acronym
P-ESD trial
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether local injection from a high-frequency knife is useful in gastric ESD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ESD procedural time
Key secondary outcomes
Mucosal incision time and speed, submucosal dissection time and speed, en bloc resection rate, complete resection rate, amount of submucosal local injective solution, number of times local injection needles were used, whether the operator changed, whether traction was used, safety endpoint: rate of adverse events (intraoperative perforation)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Standard treatment group (Group A): conventional ESD
Interventions/Control_2
Sstudy treatment group (Group B): ProKnife-ESD (P-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) Pseudo-lesions created on resected porcine gastric ESD model
(2) Tumor diameter of 30 mm or more
Key exclusion criteria
(1) Lesions spreading to the pylorus and fossa
Target sample size
68
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
TEL
+81-92-642-5286
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
TEL
+81-92-642-5286
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
+81-92-642-5286
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 | 05 | Month | 28 | 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
68
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 | 05 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 28 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 27 | Day |
Last modified on
| 2022 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050615
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
