Bleeding Rate After EGD and Colonoscopy in Patients Who Continue to Take Antithrombotic Agents

NCT ID: NCT02594813

Last Updated: 2025-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2026-12-31

Brief Summary

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The bleeding rate of both EGD (including biopsy) and colonoscopy (including biopsy, cold or hot snare polypectomy, or EMR) in patients who continue to take various antithrombotic drugs is studied prospectively. The immediate or delayed bleeding that requires hemostatic clipping or other endoscopic treatments is defined as the bleeding. Immediate bleeding requiring hemostatic clipping is defined as spurting or oozing which continued for more than 30 seconds. Delayed bleeding is defined as bleeding that requires the endoscopic treatment within 2 weeks after endoscopy. Prophylactic clipping is not performed after taking biopsy and doing polypectomy. Additionally, investigators evaluate the rate of injured submucosal arteries of the excised specimen when the bleeding occurs.

Detailed Description

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Conditions

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Bleeding After GI Endoscopy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Biopsy, cold or hot snare polypectomy, or EMR

Intervention Type PROCEDURE

Eligibility Criteria

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Exclusion Criteria

* Patients who take prophylactic clipping after biopsy or polypectomy American Society of Anesthesiologists physical status of class IV or V
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Showa Inan General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Akira Horiuchi

Chief

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Akira Horiuchi, MD

Role: PRINCIPAL_INVESTIGATOR

Showa Inan General Hospital

Locations

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Showa Inan General Hospital

Komagane, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Akira Horiuchi, MD

Role: CONTACT

0265822121

Facility Contacts

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Akira Horiuchi, MD

Role: primary

81263288528 ext. 3012

References

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Nonaka E, Horiuchi I, Horiuchi A, Ukai S, Takahata N, Oishi K. The Risk of Colonoscopy-related Bleeding in Patients With or Without Continued Treatment With an Antithrombotic Agent. DEN Open. 2025 Jul 17;6(1):e70175. doi: 10.1002/deo2.70175. eCollection 2026 Apr.

Reference Type DERIVED
PMID: 40677618 (View on PubMed)

Morita A, Horiuchi I, Tanaka N, Takada H, Graham DY, Horiuchi A. Managing bleeding risk after cold snare polypectomy in patients receiving direct-acting oral anticoagulants. Gastrointest Endosc. 2022 May;95(5):969-974. doi: 10.1016/j.gie.2022.01.005. Epub 2022 Jan 19.

Reference Type DERIVED
PMID: 35065046 (View on PubMed)

Other Identifiers

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Bleeding rate

Identifier Type: -

Identifier Source: org_study_id

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