UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055813 |
|---|---|
| Receipt number | R000063777 |
| Scientific Title | Prospective observational study of gel immersion ESD for early gastric cancer |
| Date of disclosure of the study information | 2025/01/29 |
| Last modified on | 2025/01/29 13:24:55 |
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Basic information
Public title
Prospective observational study of gel immersion ESD for early gastric cancer
Acronym
Prospective observational study of gel immersion ESD for early gastric cancer
Scientific Title
Prospective observational study of gel immersion ESD for early gastric cancer
Scientific Title:Acronym
Prospective observational study of gel immersion ESD for early gastric cancer
Region
| Japan |
Condition
Condition
early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and usefulness of gel immersion ESD for early gastric cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Trainee Endoscopists' ESD Completion Rate
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) The patient has a lesion diagnosed as early gastric cancer (including suspected gastric cancer) by endoscopy and is scheduled for ESD.
(2) The lesion must be less than 20 mm in size.
(3) Patients must be between 20 and 90 years of age at the time of enrollment.
(4) Patients have been fully informed about the study and have given their consent to participate in the study.
Key exclusion criteria
(1) Lesions larger than 20 mm
(2) Lesions extending to the pyloric ring or the spigot
(3) Postoperative stomach
(4) Patients who cannot be followed up for 14 days after ESD
(5) Patients who are deemed inappropriate by the examining physician
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Dohi |
Organization
Kyoto Prefectural University of Medicine
Division name
Molecular Gastroenterology and Hepatology, Graduate School of Medical Science
Zip code
602-8566
Address
465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5519
osamu-d@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Dohi |
Organization
Kyoto Prefectural University of Medicine
Division name
Molecular Gastroenterology and Hepatology, Graduate School of Medical Science
Zip code
602-8566
Address
465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5519
Homepage URL
osamu-d@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
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
Kyoto prefectural University of Medicine, ethics review comittee
Address
465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
Tel
075-251-5337
rinri@koto.kpu-m.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
| 2025 | Year | 01 | Month | 29 | 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 | 10 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study will be explained and consent obtained from subjects with early gastric cancer (including suspected gastric cancer) detected within one year prior to the study description date, for whom preoperative endoscopy has determined that GI-ESD is more beneficial than air-supplied ESD.
Patients will be invited to participate in the study after obtaining consent to participate in the study, and the study period will be up to 14 days after ESD when late complications may occur.
Management information
Registered date
| 2024 | Year | 10 | Month | 11 | Day |
Last modified on
| 2025 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063777
