Completed

NCT Number: NCT04328987

Safety of Cold Snare Polypectomy in Patients With Uninterrupted Antiplatelet Agent

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.

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Key information

Conditions

Post Polypectomy Bleeding

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bucheon St. Mary's Hospital

Bucheon-si, South Korea

About this study

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.)

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 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).
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.

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

Delayed post polypectomy bleeding

Time frame: From discharge of endoscopy unit until 4 weeks after polypectomy

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.

Secondary outcomes

Immediate bleeding (intraprocedural bleeding)

Time frame: until 2 minutes after polypectomy

Bleeding 2 minutes after polypectomy.

(1) no bleeding, (2) minor (negligible) bleeding, (3) major bleeding, and (4) active bleeding (spurting).

Sponsors and collaborators

Lead sponsor

Incheon St.Mary's Hospital

Other

Collaborators

Bucheon St. Mary's Hospital
Eunpyeong St. Mary's Hospital
Gangneung Asan Hospital
Keimyung University Dongsan Medical Center
Seoul St. Mary's Hospital
Soonchunhyang University Hospital
St Vincent's Hospital
Uijeongbu St. Mary's Hospital

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2023
First posted: Apr 1, 2020
Registry last updated: Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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