UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040449 |
|---|---|
| Receipt number | R000046163 |
| Scientific Title | Impact of continued use of antithrombotic drugs on the risk of delayed post-polypectomy bleeding after endoscopic mucosal resection/endoscopic submucosal dissection for gastrointestinal lesions; prospective study |
| Date of disclosure of the study information | 2020/05/19 |
| Last modified on | 2021/11/27 10:51:56 |
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Basic information
Public title
Impact of continued use of antithrombotic drugs on the risk of delayed post-polypectomy bleeding after endoscopic mucosal resection/endoscopic submucosal dissection for gastrointestinal lesions; prospective study
Acronym
Impact of antithrombotic drugs on the risk of delayed post-polypectomy bleeding after endoscopic mucosal resection/endoscopic submucosal dissection
Scientific Title
Impact of continued use of antithrombotic drugs on the risk of delayed post-polypectomy bleeding after endoscopic mucosal resection/endoscopic submucosal dissection for gastrointestinal lesions; prospective study
Scientific Title:Acronym
Impact of antithrombotic drugs on the risk of delayed post-polypectomy bleeding after endoscopic mucosal resection/endoscopic submucosal dissection
Region
| Japan |
Condition
Condition
Gastrointestinal lesions treated with endoscopic mucosal resection (including cold snare polypectomy)/ endoscopic submucosal dissection
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We assessed the impact of continued use of antithrombotic drugs on the risk of delayed post-polypectomy bleeding after endoscopic mucosal resection/endoscopic submucosal dissection for gastrointestinal lesions in order to evaluate the necessity of drug withdrawal during the peri-endoscopic period.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Rate of delayed post-polypectomy bleeding related to endoscopic procedure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
Endoscopic mucosal resection (including cold snare polypectomy)/endoscopic submucosal dissection with continued use of antithrombotic drugs
Interventions/Control_2
Endoscopic mucosal resection (including cold snare polypectomy)/endoscopic submucosal dissection with temporary cessation of antithrombotic drugs
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients with gastrointestinal lesions treated with endoscopic mucosal resection (including cold snare polypectomy)/endoscopic submucosal dissection.
2. Patients taking antithrombotic drugs.
3. Patients explained about the study protocol with comprehension, and agreed to participate with written informed consent.
Key exclusion criteria
1. Patients having another severe disorder.
2. Patients with hemostatic disorder.
3. Patients who are judged by the investigators to be inappropriate participants in the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Takeuchi |
Organization
Nagaoka Red Cross Hospital
Division name
Division of Gastroenterology and Hepatology
Zip code
940-2085
Address
2-297-1, Senshu, Nagaoka, Niigata, 940-2085, Japan
TEL
0258-28-3600
yasuzuka2000@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takamasa |
| Middle name | |
| Last name | Kobayashi |
Organization
Nagaoka Red Cross Hospital
Division name
Division of Gastroenterology and Hepatology
Zip code
940-2085
Address
2-297-1, Senshu, Nagaoka, Niigata, 940-2085, Japan
TEL
0258-28-3600
Homepage URL
tkmsjpn@gmail.com
Sponsor or person
Institute
Nagaoka Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagaoka Red Cross Hospital
Address
2-297-1, Senshu, Nagaoka, Niigata, 940-2085, Japan
Tel
0258-28-3600
shomu@nagaoka.jrc.or.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
| 2020 | Year | 05 | Month | 19 | Day |
Related information
URL releasing protocol
https://jgo.amegroups.com/article/view/54206/html
Publication of results
Published
Result
URL related to results and publications
https://jgo.amegroups.com/article/view/54206/html
Number of participants that the trial has enrolled
283
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
Completed
Date of protocol fixation
| 2019 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 05 | Month | 19 | Day |
Last modified on
| 2021 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046163
