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

Bleeding After GI Endoscopy Clinical Trial

— EGD  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02594813
• Other study ID #: Bleeding rate
• Status: Recruiting
• Start date: November 2015
• Est. completion date: December 2024

Study information

• Verified date: June 2023
• Source: Showa Inan General Hospital
• Contact: Akira Horiuchi, MD
• Phone: 0265822121
• Email: horiuchi.akira[@]sihp.jp
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The bleeding rate of both EGD (including biopsy) and colonoscopy (including biopsy or cold snare polypectomy) 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Bleeding After GI Endoscopy
• Hemorrhage

Intervention

Procedure:
• Biopsy or cold snare polypectomy

Locations

Country	Name	City	State
Japan	Showa Inan General Hospital	Komagane

Sponsors (1)

Lead Sponsor	Collaborator
Showa Inan General Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rate of delayed bleeding	Delayed bleeding defined as bleeding that required endoscopic treatment within 2 weeks after the procedure.	10 years
Secondary	the rate of immediate bleeding	Immediate bleeding defined as spurting or oozing which continued for more than 30 seconds.	10 years
Secondary	the number of clip used	The number of clip used during the procedures.	10 years