UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060230 |
|---|---|
| Receipt number | R000068889 |
| Scientific Title | Multicenter Prospective Observational Study of the Incidence of Post Endoscopic Submucosal Dissection Bleeding After Gastric ESD in Patients Receiving Antithrombotic Therapy |
| Date of disclosure of the study information | 2025/12/29 |
| Last modified on | 2025/12/29 12:18:57 |
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Basic information
Public title
A Multicenter Prospective Observational Study to Evaluate the Incidence of Post-ESD Bleeding in Patients Receiving Antithrombotic Therapy
Acronym
ATB-GESD Study
Scientific Title
Multicenter Prospective Observational Study of the Incidence of Post Endoscopic Submucosal Dissection Bleeding After Gastric ESD in Patients Receiving Antithrombotic Therapy
Scientific Title:Acronym
ATB-GESD Study
Region
| Japan |
Condition
Condition
Gastric epithelial neoplasms
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluating the incidence of post-gastric ESD bleeding in patients receiving antithrombotic therapy without second-look endoscopy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of post-gastric ESD bleeding
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who undergo ESD for gastric epithelial neoplasms
Key exclusion criteria
Patients in whom gastric ESD was discontinued
Patients who underwent closure of the post-ESD ulcer
Patients with unknown antithrombotic medication status
Patients with unknown details regarding post-ESD bleeding
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | HITOSHI |
| Middle name | |
| Last name | MORI |
Organization
Nara Medical University Hospital
Division name
Department of Gastroenterology
Zip code
634-8522
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
hitoshi-mori@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | HITOSHI |
| Middle name | |
| Last name | MORI |
Organization
Nara Medical University Hospital
Division name
Department of Gastroenterology
Zip code
634-8522
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
Homepage URL
hitoshi-mori@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
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
Nara Medical University Hospital
Address
840 Shijo-cho, Kashihara, Nara
Tel
0744-22-3051
hitoshi-mori@naramed-u.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 | 12 | 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
| 2025 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nara Prefecture General Medical Center
Bellland General Hospital
Management information
Registered date
| 2025 | Year | 12 | Month | 29 | Day |
Last modified on
| 2025 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068889
