UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040687 |
|---|---|
| Receipt number | R000046434 |
| Scientific Title | Use of endoscope tip control simulator to predict the clinical skills to perform endoscopic submucosal dissection |
| Date of disclosure of the study information | 2020/06/15 |
| Last modified on | 2020/12/08 09:18:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Use of endoscope tip control simulator to predict the clinical skills to perform endoscopic submucosal dissection
Acronym
Use of endoscope tip control simulator to predict the clinical skills to perform endoscopic submucosal dissection
Scientific Title
Use of endoscope tip control simulator to predict the clinical skills to perform endoscopic submucosal dissection
Scientific Title:Acronym
Use of endoscope tip control simulator to predict the clinical skills to perform endoscopic submucosal dissection
Region
| Japan |
Condition
Condition
early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the correlation between endoscope bowl simulator time (BST) and ESD time (ESDT)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The correlation between BST and ESDT
Key secondary outcomes
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
| 24 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Endoscopists who have performed 2 gastric ESDs or more as a primary operator in each antrum or corps for intramucosal early gastric adenocarcinomas, size 20 mm or smaller without ulceration or scar
Key exclusion criteria
ESD for lesion at the cardia or the pylorus
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Noriya |
| Middle name | |
| Last name | Uedo |
Organization
Osaka International Cancer Institute
Division name
Gastrointestinal oncology
Zip code
541-8567
Address
3-1-69, Otemae, Chuou-ku, Osaka city, Osaka
TEL
0669451181
noriya.uedo@oici.jp
Public contact
Name of contact person
| 1st name | Ayaka |
| Middle name | |
| Last name | Shoji |
Organization
Osaka International Cancer Institution
Division name
Gastrointestinal oncology
Zip code
541-8567
Address
3-1-69, Otemae, Chuou-ku, Osaka city, Osaka
TEL
0669451181
Homepage URL
syouji-ay@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka International Cancer Institute Gastrointestinal oncology
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JPN
Other related organizations
Co-sponsor
Shizuoka Cancer Center, Fukuoka University Chikushi Hospital, National Hospital Organization Osaka National Hospital, Hyogo Prefectual Nishinomiya Hospital, and Ishikawa Prefectual Central Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka International Cancer Institution
Address
3-1-69, Otemae, Chuou-ku, Osaka city, Osaka
Tel
0669451181
syouji-ay@mc.pref.osaka.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
大阪国際がんセンター
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | 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
36
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
| 2019 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 10 | Day |
Date of closure to data entry
| 2020 | Year | 05 | Month | 20 | Day |
Date trial data considered complete
| 2020 | Year | 05 | Month | 20 | Day |
Date analysis concluded
| 2020 | Year | 07 | Month | 01 | Day |
Other
Other related information
The Bowl Simulator Time (BST) was the time required to complete the task and averaged the three measurements. The ESD time (ESDT) was the time from start of marking until end of the resection for leslies in each the antrum and the corpus. Procedures that took longer than 2SD of their own average ESD time wasexcluded. We defined beginner endoscopists as those who experienced 100 cases or fewer and experienced endoscopists as those experience more than 100 cases.
Management information
Registered date
| 2020 | Year | 06 | Month | 08 | Day |
Last modified on
| 2020 | 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=R000046434
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
