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A randomized controlled, multicenter trial investigating management of Direct Oral anticoagulant (DOACs) for colorectal polypectomy

MAnagement of Direct Oral anticoagulant (DOACs) While Peripolypectomy Period: randomized A randomized controlled, mUlticenter trial - A randomized controlled trial on management of DOACs.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000039418
Enrollment
400
Registered
2020-02-08
Start date
2020-03-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal polyp

Interventions

Group to discontinuing DOACs for 1 day before lower endoscopy Group to discontinue DOACs for 1 day after endoscopic resection

Sponsors

Osaka International Cancer Institute
Lead Sponsor
Madowazu investigators
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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).

Design outcomes

Primary

MeasureTime frame
Rate of severe bleeding (uncontrolled intraoperative and postoperative bleeding) associated with polypectomy.

Secondary

MeasureTime frame
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).

Countries

Japan

Contacts

Public ContactMitsuhiro Kono

Osaka International Cancer Institute Department of Gastrointestinal Oncology

bokuri.1229@gmail.com0669451181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026