Clinical trial NCT04328987: Safety of Cold Snare Polypectomy in Patients With Uninterrupted Antiplatelet Agent
Official title: Safety of Cold Snare Polypectomy in Patients With Uninterrupted Antiplatelet Agent : Aspirin vs Clopidogrel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Polypectomy Bleeding
Keywords: antiplatelet agent
aspirin
clopidogrel
cold snare polypectomy
safety
post polypectomy bleeding
Lead sponsor: Incheon St.Mary's Hospital
Sponsor class: OTHER
Collaborators: name: Seoul St. Mary's Hospital
name: St Vincent's Hospital
name: Uijeongbu St. Mary's Hospital
name: Soonchunhyang University Hospital
name: Bucheon St. Mary's Hospital
name: Eunpyeong St. Mary's Hospital
name: Gangneung Asan Hospital
name: Keimyung University Dongsan Medical Center
First posted: 2020-04-01
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Delayed post polypectomy bleeding
timeFrame: From discharge of endoscopy unit until 4 weeks after polypectomy
Secondary outcomes:
measure: Immediate bleeding (intraprocedural bleeding)
timeFrame: until 2 minutes after polypectomy
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Bucheon St. Mary's Hospital
Study officials:
affiliation: Soonchunhyang University Hospital
name: Hyun Gun Kim, MD, Ph.D
role: STUDY_CHAIR
References: