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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039418
Receipt No. R000044714
Scientific Title MAnagement of Direct Oral anticoagulant (DOACs) While Peripolypectomy Period: randomized A randomized controlled, mUlticenter trial
Date of disclosure of the study information 2020/02/08
Last modified on 2020/02/19

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Basic information
Public title A randomized controlled, multicenter trial investigating management of Direct Oral anticoagulant (DOACs) for colorectal polypectomy
Acronym A randomized controlled trial on management of DOACs.
Scientific Title MAnagement of Direct Oral anticoagulant (DOACs) While Peripolypectomy Period: randomized A randomized controlled, mUlticenter trial
Scientific Title:Acronym A randomized controlled trial on management of DOACs.
Region
Japan

Condition
Condition Colorectal polyp
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the optimal administration period of Direct Oral Anticoagulants (DOACs) during the perioperative period of colon polypectomy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Rate of severe bleeding (uncontrolled intraoperative and postoperative bleeding) associated with polypectomy.
Key secondary outcomes Rate of postoperative bleeding without emergency endoscopic hemostasis after polypectomy
Rate of bleeding requiring blood cessation immediately after polypectomy
DOAC dose intensity ( dose intensity)
The rate of bleeding in patients who underwent only Cold Snare / Forceps Polypectomy
The rate of bleeding by the type of DOAC, the rate of adverse events (the rate of thromboembolism, Incidence).

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Group to discontinuing DOACs for 1 day before lower endoscopy
Interventions/Control_2 Group to discontinue DOACs for 1 day after endoscopic resection
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1 Person > 20 , < 80 years old
2 Patients taking direct oral anticoagulants (DOACs)
3 Appropriate informed consent.
4 PS, 0 or 1.
5 Blood test data
Platelet count > 100,000
Serum creatinine < 2.0mg / dl
PT% > 40%
6 Follow up of 30 days after treatment.

Note: Registration is possible even in cases after colorectal surgery.
Key exclusion criteria 1 Person who has registered in this test.
2 Inflammatory bowel disease, colon polyposis.
3 Patients are receiving systemic steroids, antiplatelet drugs, and multiple anticoagulants continuously. (However, patients who can respond to antiplatelet drugs according to the guidelines of the Japanese Endoscopy Society can be registered.)
4 Blood coagulation dysfunction disease.
5 Women who are pregnant, may become pregnant, or are breastfeeding.
6 Patients with psychosis or psychiatric symptoms seem to have difficulty participating in the study.
7 Active bacterial and fungal infection (has a fever of 38.5 degrees or higher and is associated with bacterial infectivity by diagnostic imaging or bacteriological examination).
8 Uncontrolled hypertension.
9 Respiratory disease requiring continuous oxygen administration.
10 Dialysis.
11 Others who are judged inappropriate by the attending physician (eg, the prescribing physician of the anticoagulant determined that participation in this study was dangerous).
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Yoji
Middle name
Last name Takeuchi
Organization Osaka International Cancer Institute
Division name Department of Gastrointestinal Oncology
Zip code 541-8567
Address Chuoku
TEL 0669451181
Email yoji.endoscopy@oici.jp

Public contact
Name of contact person
1st name Mitsuhiro
Middle name
Last name Kono
Organization Osaka International Cancer Institute
Division name Department of Gastrointestinal Oncology
Zip code 541-8567
Address Chuoku
TEL 0669451181
Homepage URL
Email bokuri.1229@gmail.com

Sponsor
Institute Osaka International Cancer Institute
Institute
Department

Funding Source
Organization Japan Gastroenterological Association
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Madowazu investigators
Name of secondary funder(s)

IRB Contact (For public release)
Organization Medical research support
Address 3-1-69 Otemae, Chuo-ku, Osaka
Tel 0669451181
Email rinri01@opho.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 02 Month 08 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
2019 Year 10 Month 31 Day
Date of IRB
2019 Year 12 Month 25 Day
Anticipated trial start date
2020 Year 03 Month 01 Day
Last follow-up date
2023 Year 02 Month 28 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 02 Month 06 Day
Last modified on
2020 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044714

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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