UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061720 |
|---|---|
| Receipt number | R000070635 |
| Scientific Title | Risk Assessment of Delayed Bleeding After Gastric Endoscopic Submucosal Dissection in Patients Receiving Anticoagulants and Validation of the Supplemented Guidelines for Gastrointestinal Endoscopy in Patients Undergoing Antithrombotic Therapy: A Multicenter Observational Study |
| Date of disclosure of the study information | 2026/05/28 |
| Last modified on | 2026/05/28 16:30:24 |
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Basic information
Public title
Risk Assessment of Delayed Bleeding After Gastric Endoscopic Submucosal Dissection in Patients Receiving Anticoagulants and Validation of the Supplemented Guidelines for Gastrointestinal Endoscopy in Patients Undergoing Antithrombotic Therapy: A Multicenter Observational Study
Acronym
Risk Assessment of Delayed Bleeding After Gastric Endoscopic Submucosal Dissection in Patients Receiving Anticoagulants and Validation of the Supplemented Guidelines for Gastrointestinal Endoscopy in Patients Undergoing Antithrombotic Therapy: A Multicenter Observational Study
Scientific Title
Risk Assessment of Delayed Bleeding After Gastric Endoscopic Submucosal Dissection in Patients Receiving Anticoagulants and Validation of the Supplemented Guidelines for Gastrointestinal Endoscopy in Patients Undergoing Antithrombotic Therapy: A Multicenter Observational Study
Scientific Title:Acronym
Risk Assessment of Delayed Bleeding After Gastric Endoscopic Submucosal Dissection in Patients Receiving Anticoagulants and Validation of the Supplemented Guidelines for Gastrointestinal Endoscopy in Patients Undergoing Antithrombotic Therapy: A Multicenter Observational Study
Region
| Japan |
Condition
Condition
Early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
When gastric ESD is performed in patients receiving DOACs according to the supplementary guidelines, the incidence of delayed gastrointestinal bleeding is expected to range from 8% to 15%. However, no large-scale multicenter study has validated the appropriateness of the supplementary guidelines. Therefore, evaluating both the safety and validity of guideline-based management strategies in patients receiving anticoagulants is an important clinical issue.In this study, we aimed to compare delayed bleeding rates before and after publication of the 2017 supplementary guidelines in patients receiving anticoagulants who underwent ESD according to the Japanese Gastric Cancer Association guidelines. We also aimed to evaluate the validity of management strategies based on the JGES supplementary guidelines for patients receiving antithrombotic therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of delayed bleeding rates before and after publication of the supplementary guidelines in anticoagulant users undergoing gastric ESD.
Key secondary outcomes
Validation of the supplementary guidelines in anticoagulant users undergoing gastric ESD.
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
1. Age >20 years.
2. Underwent ESD for early gastric cancer according to the Japanese Gastric Cancer Treatment Guidelines.
3. Receiving anticoagulants (warfarin or DOACs).
4. Underwent ESD according to the JGES Guidelines for Gastroenterological Endoscopy in Patients Undergoing Antithrombotic Treatment or the supplementary edition.
Key exclusion criteria
1. ESD discontinued due to complications (e.g., bleeding or perforation), technical difficulties, or conversion to surgical treatment.
2. Inability to complete follow-up for at least 28 days after ESD.
3. Additional photodynamic therapy (PDT) performed after ESD.
4. Histopathological evidence of invasion deeper than the muscularis propria.
5. Participation in another interventional study.
6. Refusal to allow use of clinical data.
Target sample size
1760
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Murata |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Department of Gastroenterology and Hepatology
Zip code
612-8034
Address
Kyoto-shi,fushimi-ku,Fukakusa,Mukaihatacho1-1
TEL
0756419161
mura05310531@gmail.com
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Murata |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Department of Gastroenterology and Hepatology
Zip code
612-8034
Address
Kyoto-shi,fushimi-ku,Fukakusa,Mukaihatacho1-1
TEL
0756419161
Homepage URL
mura05310531@gmail.com
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Kyoto Medical Center
Address
Kyoto-shi,fushimi-ku,Fukakusa,Mukaihatacho1-1
Tel
0756419161
mura05310531@gmail.com
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
| 2026 | Year | 05 | Month | 28 | 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
| 2022 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | 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
Not applicable
Management information
Registered date
| 2026 | Year | 05 | Month | 28 | Day |
Last modified on
| 2026 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070635
