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RecruitingNCT02594813EGDUpdated May 15, 2025

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

An observational study in Bleeding After GI Endoscopy, sponsored by Showa Inan General Hospital. Recruiting at 1 site in Japan. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-05-15.

Sponsored by Showa Inan General Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10,000
Ages
20 Years to 90 Years
Sex
All
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Study 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.

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Conditions studied

  • Bleeding After GI Endoscopy

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In context

Hemorrhage

3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 150 across 893 observational studies indexed under Hemorrhage.

Browse Hemorrhage studies →

Lead sponsor

Showa Inan General Hospital is the lead sponsor of 22 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients who continue to take antithrombotic drugs undergo EGD including biopsy and colonoscopy including biopsy, snare or hot polypectomy and/or EMR.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
10,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • ProcedureBiopsy, cold or hot snare polypectomy, or EMR
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What researchers measure

Primary outcomes

  1. the rate of delayed bleeding

    Delayed bleeding defined as bleeding that required endoscopic treatment within 2 weeks after the procedure.

    Time frame: 10 years

Secondary outcomes

  1. the rate of immediate bleeding

    Immediate bleeding defined as spurting or oozing which continued for more than 30 seconds.

    Time frame: 10 years

  2. the number of clip used

    The number of clip used during the procedures.

    Time frame: 10 years

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Study locations

1 of 1 sites recruiting
  • Showa Inan General Hospital
    Komagane, Japan
    Recruiting
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References and documents

Publications

  • 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. PubMed 35065046 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02594813
Lead sponsor
Showa Inan General Hospital
Responsible party
Akira Horiuchi (Chief, Showa Inan General Hospital) — Principal investigator
First posted
Nov 3, 2015
Start date
Nov 2015
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
May 15, 2025

Study contacts

Akira Horiuchi, MD
Contact
horiuchi.akira@sihp.jp
0265822121
Akira Horiuchi, MD
principal investigator · Showa Inan General Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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