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

NCT02594813 | Recruiting

• 1 other identifier: Bleeding rate
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Bleeding After GI Endoscopy

Outcome Measures

Primary Outcomes (1)

• the rate of delayed bleeding

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

  10 years

Secondary Outcomes (2)

• the rate of immediate bleeding

  10 years

• the number of clip used

  10 years

Interventions

Biopsy, cold or hot snare polypectomy, or EMR PROCEDURE

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Showa Inan General Hospital: lead

Study Sites (1)

Showa Inan General Hospital

Komagane, Japan

RECRUITING

Related Publications (2)

• 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 DERIVED

• 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 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Excised specimens after taking biopsy or doing polypectomy

MeSH Terms

Interventions

Biopsy; Cold Temperature

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Temperature; Thermodynamics; Physical Phenomena; Weather; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Study Officials

• Akira Horiuchi, MD

  Showa Inan General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Akira Horiuchi, MD

CONTACT

0265822121; horiuchi.akira@sihp.jp

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief

Study Record Dates

• First Submitted: October 30, 2015
• First Posted: November 3, 2015
• Study Start: November 1, 2015
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

JP (1)