UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053015 |
|---|---|
| Receipt number | R000060477 |
| Scientific Title | Effectiveness of a novel ex vivo training model for gastric endoscopic submucosal dissection training |
| Date of disclosure of the study information | 2023/12/07 |
| Last modified on | 2024/03/18 08:48:03 |
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Basic information
Public title
Effectiveness of a novel ex vivo training model for gastric endoscopic submucosal dissection training
Acronym
NExT-ESD study
Scientific Title
Effectiveness of a novel ex vivo training model for gastric endoscopic submucosal dissection training
Scientific Title:Acronym
NExT-ESD study
Region
| Japan |
Condition
Condition
Gastric Cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Gastric ESD was established as a minimally invasive treatment for early-stage gastric cancer and has become widely used. Although there are some reports on training for beginners of ESD, no system has been established yet. According to previous reports, 30 cases of ESD are required for a beginner to reach a certain skill level, but it takes a considerable amount of time for a single beginner to experience 30 cases in a limited number of cases. Recently, ESD training using a training model has been recommended, but specific methods for ESD training have not been provided. In addition, the majority of reports on ESD training have used porcine stomachs. However, in recent years, many problems have arisen from a hygienic standpoint, such as the need for a special scope when using porcine stomachs and the method of discarding the stomach after use. A new ex vivo ESD training model using a plant-based pseudo-mucosa sheet has been developed. This training model allows for the practice of procedures similar to actual ESD, without sanitary problems, and is easy to use for training. In this study, we will develop a learning curve for ESD training using the new ex vivo training model for novice trainees and examine its usefulness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ESD treatment speed is the primary endpoint of training.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Using a new ex vivo training model, four beginners will be trained for ESD 30 times per person. The training model will be set up to resect a 20 mm diameter early stage gastric cancer in one lumpectomy, and a 30 mm diameter circle marked on the mucosa sheet will be resected by ESD. The supervising physician will be present during the training and provide technical guidance.
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
Four ESD trainees
Key exclusion criteria
None
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | Takahito |
| Middle name | |
| Last name | Toba |
Organization
Toho University Omori Medical Center
Division name
Division of Gastroenterology and Hepatology
Zip code
143-8541
Address
6-11-1, Omori-nishi, Ota-ku, Tokyo 143-8541, Japan
TEL
0337624151
takahito.toba@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Takahito |
| Middle name | |
| Last name | Toba |
Organization
Toho University Omori Medical Center
Division name
Division of Gastroenterology and Hepatology
Zip code
143-8541
Address
6-11-1, Omori-nishi, Ota-ku, Tokyo
TEL
0337624151
Homepage URL
takahito.toba@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Omori Medical Center
Institute
Department
Personal name
Funding Source
Organization
Toho University Omori Medical Center
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
Ethics Committee of Toho University Medical Center Omori Hospital
Address
6-11-1, Omori-nishi, Ota-ku, Tokyo
Tel
0357636534
omori.rinri@ext.toho-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
M23178
Org. issuing International ID_1
Ethics Committee of Toho University Medical Center Omori Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 07 | 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
4
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
| 2023 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 06 | Day |
Last modified on
| 2024 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060477
