UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055937 |
|---|---|
| Receipt number | R000063925 |
| Scientific Title | Early acquisition of knife control skills by capturing the operator's gaze position during colorectal endoscopic submucosal dissection |
| Date of disclosure of the study information | 2024/12/01 |
| Last modified on | 2025/02/11 07:03:23 |
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Basic information
Public title
Early acquisition of knife control skills by capturing the operator's gaze position during colorectal endoscopic submucosal dissection
Acronym
Early acquisition of knife control skills by capturing the operator's gaze position during colorectal endoscopic submucosal dissection
Scientific Title
Early acquisition of knife control skills by capturing the operator's gaze position during colorectal endoscopic submucosal dissection
Scientific Title:Acronym
Early acquisition of knife control skills by capturing the operator's gaze position during colorectal endoscopic submucosal dissection
Region
| Japan |
Condition
Condition
Colorectal neoplasms
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify whether the use of a developed eye position analysis system to teach trainee physicians while monitoring their eye position during ESD will lead to early improvement in knife control during ESD procedures.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Coefficient of variation of distance between lesion and specimen margins
Key secondary outcomes
1. Time required for resection
2. Average resection speed
3. R0 resection rate
4. Complete en bloc resection rate
5. Complication (bleeding, perforation) rate
6. ESD completion rate
7. Change of each endpoint in 5 early and 5 late cases
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
In the intevention arm, the supervising physician will provide verbal instructions to ensure that the operator's gaze position is appropriate. During mucosal incision, the operators will be instructed to correct the viewpoint position in real time so that they can gaze exactly 5 mm from the lesion margins.
Interventions/Control_2
In the control group, the supervising physician will provide instruction as usual while viewing an endoscopic monitor rather than a PC for data acquisition/analysis.
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
| 25 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria for ESD practitioners (training physicians)
1. Trainee physicians performing ESD under the education of a supervising physician (CS experience of at least 500 cases, cecal insertion success rate of at least 95%, and polypectomy experience of at least 100 cases)
2. Physicians with less than 5 ESD experiences as an operator at the time of entry into the study
3. Physicians who have been fully informed of the study participation and have obtained written consent from them.
Inclusion criteria for ESD patients
1. Patients aged between 20 and 90 years old.
2. Patients with performance status (ECOG) of 0 (no limitation in daily activities), 1 (able to perform light work but not physical labor), or 2 (able to walk and perform personal activities but not light work).
3. Patients has been fully informed of the study and has given written consent to participate in the study
4. Patients with colorectal lesions that are eligible for ESD and have a lesion diameter of 50 mm or less
Key exclusion criteria
Exclusion criteria for ESD patients
1. Patients with lesions located in areas where endoscopic manipulation is difficult (hepatic or splenic kyphosis, etc.)
2. Patients with lesions with large elevations and fibrosis directly under the lesion
3. Patients with lesions that straddle the mucosal folds
4. Patients with lesions on or near the scar
5. Patients with lesions that the supervising physician determines unsuitable for the practitioner to treat as an operator
6. Patients who are allergic to sedative medications
7. Patients who do not consent to participate in the study
8. Patients who are deemed unsuitable by the study registrar
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Ishibashi |
| Middle name | |
| Last name | Fumiaki |
Organization
International University of Health and Welfare Ichikawa Hospital
Division name
Department of Gastroenterology
Zip code
272-0827
Address
6-1-14, Konodai, Ichikawa-shi, Chiba
TEL
047-375-1111
ishibashi-gast@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Ishibashi |
| Middle name | |
| Last name | Fumiaki |
Organization
International University of Health and Welfare Ichikawa Hospital
Division name
Department of Gastroenterology
Zip code
272-0827
Address
6-1-14, Konodai, Ichikawa-shi, Chiba
TEL
047-375-1111
Homepage URL
ishibashi-gast@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare Ichikawa Hospital
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare Ichikawa Hospital
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
NTT Medical Center Tokyo
Name of secondary funder(s)
Japan Society for the Promotion of Science
IRB Contact (For public release)
Organization
International University of Health and Welfare Institutional Review Board
Address
4-3, Kozunomori, Narita-shi, Chiba
Tel
0476-35-5613
rinri_md@iuhw.ac.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
| 2024 | Year | 12 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 24 | Day |
Last modified on
| 2025 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063925
