Safety of Cold Snare Polypectomy in Patients With Uninterrupted Antiplatelet Agent

Safety of Cold Snare Polypectomy in Patients With Uninterrupted Antiplatelet Agent : Aspirin vs Clopidogrel

Polypectomy is regarded as high risk for bleeding. Several guidelines recommend continuous use of aspirin during polypectomy. However for clopidogrel, widely used antiplatelet agent, cessation of 5-7 is recommended. There is insufficient data regarding clopidogrel on post polypectomy bleeding. Delayed bleeding after polypectomy in patients with clopidogrel was reported as 3%. A recent study showed that delayed bleeding rate in patients with clopidogrel didn't differ that of who stopped clopidogrel. However the rate for delayed bleeding was 4%, higher than the previous studies. More studies are needed to conclude the safety of polypectomy in clopidogrel users.

Cold snare polypectomy (CSP) can resect polyps without electrical energy. CSP are safe than conventional endoscopic mucosal resection in high risk for bleeding.

The polypectomy techniques in most of studies were heterogenous, where delayed bleeding was investigated in clopidogrel users. There is no study to investigate safety of CSP in patients with clopidogrel users to date. The investigators hypothesized that the bleeding risk of CSP in patients with clopidogrel users would be similar to that of aspirin users.

In this multicenter prospective study, the investigators aimed to compare the safety of CSP between aspirin and clopidogrel users.

Study Overview

• Status: Completed
• Conditions: Post Polypectomy Bleeding
• Intervention / Treatment: Procedure: cold snare polypectomy

Detailed Description

• Cold snare polypectomy (CSP): resection of colorectal polyp by mechanical force of snare, without electric cautery.
• Antiplatelet agent: single use of aspirin or clopidogrel
• Uninterrupted (continuous) use of antiplatelet agent: cessation of antiplatelet agent less than 4 days. Cessation of antiplatelet agent is sum of before and after the CSP

ex.)

1. patient who stopped aspirin only on the day of colonoscopy and resumed the day after colonoscopy -> cessation of aspirin was 1 day.
2. patient who stopped aspirin only on the day of colonoscopy and resumed the 2 days after colonoscopy -> cessation of aspirin was 2 days (before colonoscopy 1day + after colonoscopy 1day).
3. patient who stopped aspirin from 3 days before colonoscopy and resumed the day after colonoscopy -> cessation of aspirin was 4 days (-3, -2, -1, 0=on the day of colonoscopy). -> interruption of aspirin -> excluded from study.

4. patient who stopped aspirin from 2 days before colonoscopy and resumed 2 days after colonoscopy -> cessation of aspirin was 4 days (-2, -1, 0=on the day of colonoscopy, 1=the day after colonoscopy). -> interruption of aspirin -> excluded from study.

   • BLEEDING # Immediate (intraprocedural) bleeding After CSP, bleeding will be observed for 2 minutes. Bleeding grade: (1) no bleeding, (2) minor (negligible) bleeding, (3) major bleeding, and (4) active bleeding (spurting).

In case of Grade 3 or 4, hemoclipping will be applied

• Delayed bleeding Delayed bleeding will be defined when all of the following criteria were met: (1) anal bleeding after discharge of endoscopy unit and (2) identification of polypectomy bleeding site by colonoscopy.
• Significant delayed bleeding Any of the following criteria: (1) hemoglobin drop >2, (2) hemodynamic instability, (3) admission, (4) transfusion, and (5) surgery or angiography for hemostasis.

• Study Type: Observational
• Enrollment (Actual): 314

Contacts and Locations

• Study Contact: Name: Tae-Geun Gweon, MD, Ph.D; Phone Number: 82 10 3753 5124; Email: gweontae@naver.com
• Study Contact Backup: Name: Taeho Kim, MD, Ph.D; Phone Number: 82 10 2209 4742; Email: drkimtaeho@gmail.com

Study Locations

• Korea, Republic of
  • Bucheon, Korea, Republic of
    • Bucheon St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

* Uninterrupted (continuous) use of antiplatelet agent: cessation of antiplatelet agent less than 4 days. Cessation of antiplatelet agent is sum of before and after the CSP

ex.)

1. patient who stopped aspirin only on the day of colonoscopy and resumed the day after colonoscopy -> cessation of aspirin was 1 day.

   (before colonoscopy 1day + after colonoscopy 1day).

2. patient who stopped aspirin from 2 days before colonoscopy and resumed 2 days after colonoscopy -> cessation of aspirin was 4 days (-2, -1, 0=on the day of colonoscopy, 1=the day after colonoscopy). -> interruption of aspirin -> excluded from study.

Description

Inclusion Criteria:

• aged 18-80
• polyp size <10mm
• polyp resection : cold snare polypectomy
• cessation of antiplatelet agent less than 4 days

Exclusion Criteria:

• ASA class IV or above,
• hematologic diseases including idiopathic thrombocytopenic purpura, leukemia, and aplastic anemia
• advanced liver cirrhosis
• cessation of antiplatelet agent for 4 days or more
• dual antiplatelet agent users
• coagulopathy (abnormal PT, aPTT, or platelet count)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Clopidogrel user; * Uninterrupted (continuous) use of clopidogrel: cessation of clopidogrel less than 4 days (=0, 1, 2, or 3 days cessation). Cessation days of clopidogrel is sum of before and after the CSP; patient who stopped clopidogrel only on the day of colonoscopy and resumed the day after colonoscopy -> cessation of clopidogrel was 1 day.; patient who stopped clopidogrel from 3 days before colonoscopy and resumed the day after colonoscopy -> cessation of clopidogrel was 4 days (-3, -2, -1, 0=on the day of colonoscopy). -> interruption of clopidogrel -> excluded from study.; patient who stopped clopidogrel from 2 days before colonoscopy and resumed 2 days after colonoscopy -> cessation of clopidogrel was 4 days (-2, -1, 0=on the day of colonoscopy, 1=the day after colonoscopy). -> interruption of clopidogrel -> excluded from study.	Procedure: cold snare polypectomy; Resection of colorectal polyp using cold snare polypectomy method. The polyp will be resected by mechanical force of snare without electrical cautery.
Aspirin user; * Uninterrupted (continuous) use of aspirin: cessation of aspirin less than 4 days (=0, 1, 2, or 3 days cessation). Cessation days of aspirin is sum of before and after the CSP; patient who stopped aspirin only on the day of colonoscopy and resumed the day after colonoscopy -> cessation of aspirin was 1 day.; patient who stopped aspirin from 3 days before colonoscopy and resumed the day after colonoscopy -> cessation of aspirin was 4 days (-3, -2, -1, 0=on the day of colonoscopy). -> interruption of aspirin -> excluded from study.; patient who stopped aspirin from 2 days before colonoscopy and resumed 2 days after colonoscopy -> cessation of aspirin was 4 days (-2, -1, 0=on the day of colonoscopy, 1=the day after colonoscopy). -> interruption of aspirin -> excluded from study.	Procedure: cold snare polypectomy; Resection of colorectal polyp using cold snare polypectomy method. The polyp will be resected by mechanical force of snare without electrical cautery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delayed post polypectomy bleeding	Delayed bleeding will be defined when all of the following criteria were met: (1) anal bleeding after discharge of endoscopy unit and (2) identification of polypectomy bleeding site by colonoscopy.	From discharge of endoscopy unit until 4 weeks after polypectomy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immediate bleeding (intraprocedural bleeding)	Bleeding 2 minutes after polypectomy. (1) no bleeding, (2) minor (negligible) bleeding, (3) major bleeding, and (4) active bleeding (spurting).	until 2 minutes after polypectomy

Collaborators and Investigators

• Sponsor: Incheon St.Mary's Hospital
• Collaborators: Seoul St. Mary's Hospital; Keimyung University Dongsan Medical Center; Soonchunhyang University Hospital; St Vincent's Hospital; Bucheon St. Mary's Hospital; Gangneung Asan Hospital; Uijeongbu St. Mary's Hospital; Eunpyeong St. Mary's Hospital
• Investigators: Study Chair: Hyun Gun Kim, MD, Ph.D, Soonchunhyang University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: March 28, 2020
• First Submitted That Met QC Criteria: March 28, 2020
• First Posted (Actual): April 1, 2020

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: safety; clopidogrel; aspirin; antiplatelet agent; cold snare polypectomy; post polypectomy bleeding
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: XC19OCDI0089

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No