UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053420 |
|---|---|
| Receipt number | R000060971 |
| Scientific Title | Prospective Study on the Diagnostic Efficacy of Early Gastric Cancer Using a New Thin Scope for EG-840TP |
| Date of disclosure of the study information | 2024/01/31 |
| Last modified on | 2024/01/23 21:02:29 |
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Basic information
Public title
Prospective Study on the Diagnostic Efficacy of Early Gastric Cancer Using a New Thin Scope for EG-840TP
Acronym
Prospective Study on the Diagnostic Efficacy of Early Gastric Cancer Using a New Thin Scope for EG-840TP
Scientific Title
Prospective Study on the Diagnostic Efficacy of Early Gastric Cancer Using a New Thin Scope for EG-840TP
Scientific Title:Acronym
Prospective Study on the Diagnostic Efficacy of Early Gastric Cancer Using a New Thin Scope for EG-840TP
Region
| Japan |
Condition
Condition
early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the diagnostic ability of EG-840TP in early gastric cancer and to clarify the usefulness of EG-840TP in screening.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnosis results of Trainee and Expert
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing endoscopic submucosal dissection (ESD) for early gastric cancer or suspected early gastric cancer.
Consent to participate in the study was obtained on paper.
Over 18 years old.
Key exclusion criteria
Postoperative stomach.
Patients with multiple epithelial tumors (including suspected lesions)
Patients who are judged to be inappropriate for this study by the principal investigator or subcontractor.
Patients allergic to propofol, pentazocine, and lidocaine.
Patients who are pregnant or breastfeeding.
Target sample size
175
Research contact person
Name of lead principal investigator
| 1st name | tomohiro |
| Middle name | |
| Last name | shimada |
Organization
Sendai City Medical Center
Division name
Department of Gastroenterology
Zip code
9830824
Address
5-22-1, Tsurugaya, Miyagino-ku Sendai-shi, Miyagi-ken, Japan
TEL
0222521111
t.shimada@openhp.or.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | shimada |
Organization
Sendai City Medical Center
Division name
Department of Gastroenterology
Zip code
9830824
Address
5-22-1, Tsurugaya, Miyagino-ku Sendai-shi, Miyagi-ken, Japan
TEL
09067892904
Homepage URL
t.shimada@openhp.or.jp
Sponsor or person
Institute
Sendai City 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
Sendai City Medical Center
Address
5-22-1, Tsurugaya, Miyagino-ku Sendai-shi, Miyagi-ken, Japan
Tel
0222521111
t.shimada@openhp.or.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 | 01 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation procedure
The examiner uses the EG-840TP to observe the inside of the stomach before performing ESD marking operations. The ESD physician (recorder) knows the information on the target lesion that is scheduled for treatment, but does not communicate anything to the examiner other than that there is early gastric cancer or a lesion suspected of being early gastric cancer. 1, Perform intragastric screening for approximately 3 minutes using white light imaging (WLI). 2, When the area of interest is recognized, take a photo and report the area, circumference, and photo number to the recorder. After that, imaging and diagnosis using close observation: cancer (high confidence) / cancer (low confidence) / non-cancer, switching to BLI imaging and diagnosis: cancer (high confidence) / cancer (low confidence) / Report to the recorder that you are cancer-free. 3, After the observation is complete, switch to BLI and perform additional observation for about 1 minute. When an area of interest is recognized with BLI, images are taken, diagnosed, and recorded using the same procedure as above (close-up observation is performed in the order of BLI and WLI). 4, Next, the other examiner performs the examination using the method described above. In addition, for cases with odd numbered cases, the procedure will be performed in the order of Trainee and then Expert, and for even numbered cases, the procedure will be performed in the order of Expert and Trainee. 5, The recorder records the areas of interest and diagnoses pointed out by the examiner on the case record form (CRF). The final diagnosis of the region of interest is performed as follows. The day after ESD, magnified observation of the region of interest with BLI is performed using EG-760Z, and if it is diagnosed as non-cancerous (high confidence), it is considered non-cancerous. If the patient is non-cancerous (low certainty) or cancer is suspected, the diagnosis is confirmed by biopsy.
Management information
Registered date
| 2024 | Year | 01 | Month | 23 | Day |
Last modified on
| 2024 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060971
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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