Safety of Cold Snare Polypectomy in Patients With Uninterrupted Antiplatelet Agent

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

314 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-10

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety of Continuing Anti-platelet Agents During Colonoscopic Polypectomy: A Prospective Study

NCT01647568

Post-polypectomy Bleeding Anti-platelet Therapy Colonoscopy

COMPLETED

Platelet Inhibition and Bleeding in Patients Undergoing Emergent Cardiac Surgery

NCT01468597

Bleeding

COMPLETED

Occurrence of Bleeding and Thrombosis During Antiplatelet Therapy in Non-cardiac Surgery

NCT01358422

Bleeding Thrombosis Cardiac Events

COMPLETED

Prevention of Post-Polypectomy Colorectal Bleeding by Clips in Patients on Anticoagulants

NCT07007598

Polyp of Colon

RECRUITING

Hemorrhage Following Small Polyp Resection in the Colon in Anticoagulated Patients

NCT02375646

Post Polypectomy Bleeding in Anticoagulated Patients Gastrointestinal Hemorrhage

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

* 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post Polypectomy Bleeding

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

cold snare polypectomy

Intervention Type 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

\* 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.

cold snare polypectomy

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No