Safety of Cold Snare Polypectomy in Patients With Uninterrupted Antiplatelet Agent

Sponsor

Incheon St.Mary's Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT04328987

Collaborator

Seoul Hospital, Soonchunhyang University (Other), St. Vincent's Hospital-Manhattan (Other), Uijeongbu St. Mary's Hospital, The Catholic University of Korea (Other), Soonchunhyang University Cheonan Hospital (Other), Bucheon St. Mary's Hospital (Other), Eunpyeong St. Mary's Hospital, The Catholic University of Korea (Other), Soonchunhyang University Hospital (Other), Gangneung Asan Hospital (Other), Kyemyoung University Dongsan Medical Center (Other)

314

Enrollment

Location

20.7

Anticipated Duration (Months)

15.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post Polypectomy Bleeding	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.)

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

314 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 10, 2020

Anticipated Primary Completion Date :

Dec 31, 2020

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Delayed post polypectomy bleeding [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 Outcome Measures

Immediate bleeding (intraprocedural bleeding) [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

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)