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

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.

Study Overview

• Status: Recruiting
• Conditions: Bleeding After GI Endoscopy
• Intervention / Treatment: Procedure: Biopsy, cold or hot snare polypectomy, or EMR

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Akira Horiuchi, MD; Phone Number: 0265822121; Email: horiuchi.akira@sihp.jp

Study Locations

• Japan
  • Komagane, Japan
    • Recruiting
    • Showa Inan General Hospital
    • Contact: Akira Horiuchi, MD; Phone Number: 3012 81263288528; Email: horiuchi.akira@sihp.jp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 86 years (Adult, Older Adult)
• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the rate of delayed bleeding	Delayed bleeding defined as bleeding that required endoscopic treatment within 2 weeks after the procedure.	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the rate of immediate bleeding	Immediate bleeding defined as spurting or oozing which continued for more than 30 seconds.	10 years
the number of clip used	The number of clip used during the procedures.	10 years

Collaborators and Investigators

• Sponsor: Showa Inan General Hospital
• Investigators: Principal Investigator: Akira Horiuchi, MD, Showa Inan General Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 30, 2015
• First Submitted That Met QC Criteria: October 30, 2015
• First Posted (Estimated): November 3, 2015

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: Bleeding rate