UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055875 |
|---|---|
| Receipt number | R000062493 |
| Scientific Title | Outside-lesion Clip-Thread Method for Gastric ESD: Multicenter Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/10/18 |
| Last modified on | 2025/04/19 11:09:15 |
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Basic information
Public title
Efficacy of Outside-lesion Clip-Thread Method for Gastric Endoscopic Submucosal Dissection of Lesions of the Greater Curvature of the Upper/Middle Stomach: Multicenter Randomized Controlled Trial
Acronym
Outside-lesion Clip-Thread Method for Gastric ESD
Scientific Title
Outside-lesion Clip-Thread Method for Gastric ESD: Multicenter Randomized Controlled Trial
Scientific Title:Acronym
O-CTM study
Region
| Japan |
Condition
Condition
early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of ESD using O-CTM by comparing the procedure time of ESD using O-CTM with that of conventional ESD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
procedure time
Key secondary outcomes
Resection speed, R0 resection rate, En bloc resection rate, Adverse events, percentage of surgeon change from non-expert to expert, percentage of change from O-CTM to control method.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Control ESD
Interventions/Control_2
O-CTM ESD
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who are at least 20 years old.
2) Patients with ECOG-PS 0,1.
3) Patients who have obtained written consent from the patient.
4) Patients whose major organ functions (bone marrow, heart, liver, lungs, kidneys, etc.) are preserved.
5) Neoplastic lesions are defined as lesions diagnosed as adenoma on biopsy prior to ESD or gastric cancer, and the following lesions listed in the ESD/EMR Guidelines for Gastric Cancer (2nd Edition).
i) UL0 gross intramucosal carcinoma (cT1a) of 2 cm or less in length, differentiated carcinoma
ii) cT1a, differentiated carcinoma of UL0 greater than 2 cm in length
iii) cT1a, differentiated carcinoma in UL1 with a diameter of 3 cm or less
iv) cT1a, undifferentiated carcinoma of UL0 less than 2 cm in length
Key exclusion criteria
1) Postoperative gastric cases.
2) Patients in which the lesion is in the vicinity of a scar from a previous endoscopic procedure.
2) Patients with concurrent multiple lesions and multiple lesions to be resected in a single ESD.
3) Patients who have been previously enrolled in this study.
4) Patients deemed inappropriate for this study by the treating physician.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Tajika |
Organization
Aichi cancer center
Division name
endoscopy
Zip code
464-8681
Address
1-1, kanokoden, chikusaku, nagoya city, Aichi, Japan
TEL
0527626111
mtajika@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Keisaku |
| Middle name | |
| Last name | Yamada |
Organization
Aichi cancer center
Division name
Endscopy
Zip code
464-8681
Address
1-1, kanokoden, chikusaku, nagoya city, Aichi, Japan
TEL
0527626111
Homepage URL
k.yamada@aichi-cc.jp
Sponsor or person
Institute
Aichi cancer 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
Aichi cancer center
Address
1-1, kanokoden, chikusaku, nagoya city, Aichi, Japan
Tel
0527626111
irb@aichi-cc.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 | 10 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2027 | Year | 12 | 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
| 2024 | Year | 10 | Month | 18 | Day |
Last modified on
| 2025 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062493
