UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041827 |
|---|---|
| Receipt number | R000047750 |
| Scientific Title | Ex vivo porcine model study on the treatment outcomes of scissor-type knife versus needle-type knife in endoscopic submucosal dissection performed by trainees |
| Date of disclosure of the study information | 2020/09/17 |
| Last modified on | 2020/09/17 18:32:58 |
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Basic information
Public title
Ex vivo porcine model study on the treatment outcomes of scissor-type knife versus needle-type knife in endoscopic submucosal dissection performed by trainees
Acronym
Ex vivo porcine model study on the treatment outcomes of scissor-type knife versus needle-type knife in endoscopic submucosal dissection performed by trainees
Scientific Title
Ex vivo porcine model study on the treatment outcomes of scissor-type knife versus needle-type knife in endoscopic submucosal dissection performed by trainees
Scientific Title:Acronym
Ex vivo porcine model study on the treatment outcomes of scissor-type knife versus needle-type knife in endoscopic submucosal dissection performed by trainees
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
we compared the treatment outcomes of ESD between the scissor-type and needle-type endo-knives in-terms of their efficacy and safety.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome was the procedure time for ESD
Key secondary outcomes
The secondary outcomes included the mucosal incision time, submucosal dissection time, self-completion rate, en bloc resection rate, and rates of complications (muscular injury and intraoperative perforation)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
none
Key exclusion criteria
none
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | mitsuru |
| Middle name | |
| Last name | Esaki |
Organization
Nihon University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Medicine
Zip code
1010062
Address
1-6 Kanda-Surugadai, Chiyoda-ku,
TEL
+81-3-3293-1711
esaki_saiseikai@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Ryoji |
| Middle name | |
| Last name | Ichijima |
Organization
Nihon University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Medicine
Zip code
1010062
Address
1-6 Kanda-Surugadai, Chiyoda-ku
TEL
09077002403
Homepage URL
ryoji0331@yahoo.co.jp
Sponsor or person
Institute
Kitakyushu Municipal Medical Center
Institute
Department
Personal name
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
Kitakyushu Municipal Medical Center
Address
1-1, Kokurakita-ku, kitakyushu
Tel
093-541-1831
ryoji0331@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
| 2020 | Year | 09 | Month | 17 | 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
22
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
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective observational study
Management information
Registered date
| 2020 | Year | 09 | Month | 17 | Day |
Last modified on
| 2020 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047750
