Safety of Cold Snare Polypectomy in Patients With Uninterrupted Antiplatelet Agent

NCT04328987 | Completed DMC

• 1 other identifier: XC19OCDI0089
• Study Type: observational
• Target: 314
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Polypectomy Bleeding

Keywords

antiplatelet agent; aspirin; clopidogrel; cold snare polypectomy; safety; post polypectomy bleeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Immediate bleeding (intraprocedural bleeding)

  until 2 minutes after polypectomy

Study Arms (2)

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 1. patient who stopped clopidogrel only on the day of colonoscopy and resumed the day after colonoscopy -\> cessation of clopidogrel was 1 day. 2. 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. 3. 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

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 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 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. 3. 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

Interventions

cold snare polypectomy PROCEDURE

Resection of colorectal polyp using cold snare polypectomy method. The polyp will be resected by mechanical force of snare without electrical cautery.

Aspirin user; Clopidogrel user

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Incheon St.Mary's Hospital: lead
• Seoul St. Mary's Hospital: collaborator
• St Vincent's Hospital: collaborator
• Uijeongbu St. Mary's Hospital: collaborator
• Soonchunhyang University Hospital: collaborator
• Bucheon St. Mary's Hospital: collaborator
• Eunpyeong St. Mary's Hospital: collaborator
• Gangneung Asan Hospital: collaborator
• Keimyung University Dongsan Medical Center: collaborator

Study Sites (1)

Bucheon St. Mary's Hospital

Bucheon-si, South Korea

Location

Related Publications (1)

• Gweon TG, Kim HG, Jung Y, Jeon SR, Na SY, Lee YJ, Kim TH. Safety of cold snare resection techniques for removal of polyps in the small colon in patients taking clopidogrel and aspirin: a Korean Association for the Study of Intestinal Diseases prospective multicenter study. Gastrointest Endosc. 2025 Apr;101(4):866-876. doi: 10.1016/j.gie.2024.10.014. Epub 2024 Oct 16.

  PMID: 39424007 DERIVED

Study Officials

• Hyun Gun Kim, MD, Ph.D

  Soonchunhyang University Hospital

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: March 28, 2020
• First Posted: April 1, 2020
• Study Start: April 10, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2023
• Last Updated: February 8, 2024

Record last verified: 2024-02

Locations

KR (1)