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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040449
Receipt No. 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 2020/05/19

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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
Email 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
Email tkms0927@med.niigata-u.ac.jp

Sponsor
Institute Nagaoka Red Cross Hospital
Institute
Department

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
Email 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
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
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
2020 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046163

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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