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Recruiting NCT02594813

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

Observational Bleeding After GI Endoscopy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biopsy, cold or hot snare polypectomy, or EMR.
Who it may be relevant to
Registry conditions: Bleeding After GI Endoscopy. Basic parameters: 20 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Procedure Biopsy, cold or hot snare polypectomy, or EMR

Primary outcome measures

  • the rate of delayed bleeding [Time frame: 10 years]
Secondary outcome measures (2)
  • the rate of immediate bleeding [Time frame: 10 years]
  • the number of clip used [Time frame: 10 years]

Eligibility criteria

Inclusion criteria

  • Inclusion criteria is all patients who continue to take antithrombotic drugs and undergo EGD or colonoscopy

Exclusion criteria

  • Patients who take prophylactic clipping after biopsy or polypectomy American Society of Anesthesiologists physical status of class IV or V

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Japan · 1 center
  • Showa Inan General Hospital — Komagane

Publications

  • 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. PMID 40677618
  • 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. PMID 35065046

Identifiers

NCT: NCT02594813 · Bleeding rate

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗