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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02594813
Acronym
EGD
Enrollment
10000
Registered
2015-11-03
Start date
2015-11-30
Completion date
2026-12-31
Last updated
2025-05-15

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

Conditions

Bleeding After GI Endoscopy

Brief summary

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

PROCEDUREBiopsy, cold or hot snare polypectomy, or EMR

Sponsors

Showa Inan General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the rate of delayed bleeding10 yearsDelayed bleeding defined as bleeding that required endoscopic treatment within 2 weeks after the procedure.

Secondary

MeasureTime frameDescription
the rate of immediate bleeding10 yearsImmediate bleeding defined as spurting or oozing which continued for more than 30 seconds.
the number of clip used10 yearsThe number of clip used during the procedures.

Countries

Japan

Contacts

Primary ContactAkira Horiuchi, MD
horiuchi.akira@sihp.jp0265822121

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026