UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050792 |
|---|---|
| Receipt number | R000057880 |
| Scientific Title | Risk assessment of bleeding after gastric submucosal dissection in patients taking anticoagulant drugs and validity evaluation of supplemented guideline for gastrointestinal endoscopy in patients taking antithrombotic drugs: multicenter observational study |
| Date of disclosure of the study information | 2023/04/09 |
| Last modified on | 2023/04/09 17:16:43 |
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Basic information
Public title
Risk assessment of bleeding after gastric submucosal dissection in patients taking anticoagulant drugs and validity evaluation of supplemented guideline for gastrointestinal endoscopy in patients taking antithrombotic drugs: multicenter observational study
Acronym
Risk assessment of bleeding after gastric submucosal dissection in patients taking anticoagulant drugs and validity evaluation of supplemented guideline for gastrointestinal endoscopy in patients taking antithrombotic drugs: multicenter observational study
Scientific Title
Risk assessment of bleeding after gastric submucosal dissection in patients taking anticoagulant drugs and validity evaluation of supplemented guideline for gastrointestinal endoscopy in patients taking antithrombotic drugs: multicenter observational study
Scientific Title:Acronym
Risk assessment of bleeding after gastric submucosal dissection in patients taking anticoagulant drugs and validity evaluation of supplemented guideline for gastrointestinal endoscopy in patients taking antithrombotic drugs: multicenter observational study
Region
| Japan |
Condition
Condition
early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the postoperative bleeding rate before and after the publication of the Guideline for Gastrointestinal Endoscopy for Patients Taking Antithrombotic Drugs (Amendment 2017), targeting cases of patients taking anticoagulants who underwent ESD according to the guidelines of the Japan Gastric Cancer Society. , and to evaluate the adequacy of management in accordance with the guidelines for gastrointestinal endoscopy for patients taking antithrombotic drugs.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the postoperative bleeding rate before and after the revised guideline in patients taking antithrombotic drugs during gastric ESD in patients taking anticoagulants.
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
1. Those who are 20 years of age or older
2. Those who have undergone ESD treatment for early gastric cancer in accordance with the "Stomach Cancer Treatment Guidelines" edited by the Japan Gastric Cancer Society
3. Those taking anticoagulants (warfarin or DOAC)
4. Those who have undergone ESD treatment for early gastric cancer in accordance with the "Guidelines for Gastrointestinal Endoscopy for Patients Taking Antithrombotic Drugs" edited by the Japan Gastroenterological Endoscopy Society or its supplements.
Key exclusion criteria
1. Patients who discontinued ESD or underwent surgical treatment due to complications (bleeding, perforation, etc.) or technical reasons during ESD.
2. Those who have not been able to follow up for more than 28 days after ESD
3. Subjects who received additional photodynamic therapy (PDT) after ESD
4. Patients with infiltration deeper than the muscle layer in histopathological evaluation of the resected specimen
5. Patients participating in other interventional trials
6. Those who refuse to use clinical data
Target sample size
1740
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
Zip code
612-8555
Address
1-1, Mukouhata-Cho, Fukakusa, Fushimi-ku, Kyoto, Japan
TEL
+81756419161
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
Zip code
612-8555
Address
1-1, Mukouhata-Cho, Fukakusa, Fushimi-ku, Kyoto, Japan
TEL
+81756419161
Homepage URL
mura05310531@gmail.com
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Kyoto Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Medical University
Kyoto Medical Center
University of Tokyo
Tohoku University
National Cancer Center Hospital
Fukushima Medical University Hospital
University of Tsukuba Hospital
Hirosaki University
Toyonaka Municipal Hospital
Jikei University Hospital
National Center for Global Health and Medicine Konodai Hospital
Hamamatsu University School of Medicine
Tokyo Metropolitan Bokuto Hospital
Iwate Medical University
Seirei Hamamatsu Hospital
Nihon University
Kansai Rosai Hospital
Kagawa University Medical School Hospital
Yamaguchi University Graduate School
Cancer Research Ariake Hospital
Sendai Kosei Hospital
Osaka Public University
Osaka University
Wakayama Medical University
Hyogo College of Medicine
Osaka Municipal General Medical Center
Tonan Hospital
Chiba University
Ehime University Hospital
Ishikawa Prefectural Central Hospital
Shizuoka Cancer Center
Gunma University Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Kyoto Medical Center
Address
1-1, Mukouhata-Cho, Fukakusa, Fushimi-ku, Kyoto, Japan
Tel
+81756419161
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
| 2023 | Year | 04 | Month | 09 | 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
1740
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Aims
1. Evaluation of the postoperative bleeding rate before and after the revised guideline in patients taking antithrombotic drugs during gastric ESD in patients taking anticoagulants
2. Validity evaluation of the supplemented guideline in patients taking antithrombotic drugs during gastric ESD in patients taking anticoagulants
Management information
Registered date
| 2023 | Year | 04 | Month | 09 | Day |
Last modified on
| 2023 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057880
