Post Polypectomy BleedingNCT04328987
Safety of Cold Snare Polypectomy in Patients With Uninterrupted Antiplatelet Agent
An observational study of Post Polypectomy Bleeding, run by Incheon St.Mary's Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post Polypectomy Bleeding
- What is being tested?
- cold snare polypectomy
- Type of treatment
- Surgery or procedure
- How many people
- 314 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Apr 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- aged 18-80
- polyp size <10mm
- polyp resection : cold snare polypectomy
- cessation of antiplatelet agent less than 4 days
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety of Cold Snare Polypectomy in Patients With Uninterrupted Antiplatelet Agent : Aspirin vs Clopidogrel
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.
Read more
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.
Read the 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.
- Conditions
- Post Polypectomy Bleeding
- Being tested
- cold snare polypectomy
- Keywords
- antiplatelet agent, aspirin, clopidogrel, cold snare polypectomy, safety, post polypectomy bleeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cold snare polypectomyProcedure or surgery
Resection of colorectal polyp using cold snare polypectomy method. The polyp will be resected by mechanical force of snare without electrical cautery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: cold snare polypectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From discharge of endoscopy unit until 4 weeks after polypectomy
Secondary outcomes (1)
Immediate bleeding (intraprocedural bleeding)
Bleeding 2 minutes after polypectomy.
(1) no bleeding, (2) minor (negligible) bleeding, (3) major bleeding, and (4) active bleeding (spurting).
Measured: until 2 minutes after polypectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start10 Apr 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Polypectomy BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incheon St.Mary's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul St. Mary's Hospital, St Vincent's Hospital, Uijeongbu St. Mary's Hospital, Soonchunhyang University Hospital, Bucheon St. Mary's Hospital, Eunpyeong St. Mary's Hospital, Gangneung Asan Hospital, Keimyung University Dongsan Medical Center
- Responsible party
- Principal investigator, Tae-Geun Gweon, Incheon St.Mary's Hospital
- Investigators
- Hyun Gun Kim, MD, Ph.D, Study chair, Soonchunhyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328987
- Sponsor's protocol ID
- XC19OCDI0089
- Status last verified
- Feb 2024
- First submitted
- 28 Mar 2020
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39424007
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Cold Snare Polypectomy in Patients With Uninterrupted Antiplatelet Agent : Aspirin vs Clopidogrel
- ClinicalTrials.gov ID
- NCT04328987
- Acronym / sponsor ID
- XC19OCDI0089
- Conditions
- Post Polypectomy Bleeding
- Keywords
- antiplatelet agent, aspirin, clopidogrel, cold snare polypectomy, safety, post polypectomy bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Incheon St.Mary's HospitalUniversity, hospital or other
- Collaborators
- Seoul St. Mary's Hospital, St Vincent's Hospital, Uijeongbu St. Mary's Hospital, Soonchunhyang University Hospital, Bucheon St. Mary's Hospital, Eunpyeong St. Mary's Hospital, Gangneung Asan Hospital, Keimyung University Dongsan Medical Center
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 1 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.)
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel user | – | Procedure: cold snare polypectomy* 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. |
| Aspirin user | – | Procedure: cold snare polypectomy* 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- aged 18-80
- polyp size <10mm
- polyp resection : cold snare polypectomy
- cessation of antiplatelet agent less than 4 days
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cold snare polypectomyResection of colorectal polyp using cold snare polypectomy method. The polyp will be resected by mechanical force of snare without electrical cautery. | Procedure or surgery | Aspirin user, Clopidogrel user |
Primary outcome
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.
1 secondary outcome
Immediate bleeding (intraprocedural bleeding)
Time frame: until 2 minutes after polypectomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Derived from this study: PubMed 39424007Gweon 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.
- Individual participant dataSharing planned: Undecided
Related trials for Post Polypectomy Bleeding
Active, not recruiting
Blood Flow Monitoring to Prevent Post-Polypectomy Induced Ulcer Bleeding
Delayed Post-Polypectomy Induced Ulcer Hemorrhage
RecruitingPhase 3
Aspirin Continuation or Interruption in Patients at Moderate Risk for Cardiovascular Events Undergoing Colonoscopy and/or Polypectomy
Myocardial Infarction (MI), Cardiovascular Events
Not yet recruitingPhase 4
Prevention of Delayed Post-polypectomy Bleeding by Endoscopic Sucralfate Spray in High-risk Patients: A Randomized Controlled Trial
Bleeding After GI Endoscopy
RecruitingObservational study
Prevention of Post-Polypectomy Colorectal Bleeding by Clips in Patients on Anticoagulants
Polyp of Colon
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyun Gun Kim, MD, Ph.D study chair
Soonchunhyang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Polypectomy Bleeding, run by Incheon St.Mary's Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delayed post polypectomy bleeding (time frame: From discharge of endoscopy unit until 4 weeks after polypectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04328987, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.