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

Recruiting

• Conditions: Bleeding After GI Endoscopy

• Registration Number: NCT02594813
• Lead Sponsor: Showa Inan General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-30
• Study First Submitted QC: 2015-10-30
• Study Start: 2015-11
• Study First Posted: 2015-11-03
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-20
• Last Update Posted: 2024-07-23
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

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

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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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the rate of delayed bleeding	10 years	Delayed bleeding defined as bleeding that required endoscopic treatment within 2 weeks after the procedure.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Showa Inan General Hospital; 🇯🇵 Komagane, Japan