Bleeding Complication During Colon PolypectomyNCT01465256
Postpolypectomy Bleeding in Patients With Antiplatelet Therapy
A study testing Aspirin in people with Bleeding Complication During Colon Polypectomy, run by Soonchunhyang University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to determine if the use of aspirin prior to colonoscopy increases the risk of post polypectomy bleeding. The primary end point is comparison of bleeding rates after polypectomy of a continuous aspirin group and temporally aspirin-quit group. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Bleeding Complication During Colon Polypectomy
- What is being tested?
- Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2012to Jun 2014
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The patients who take low dose aspirin (75~160mg) for primary prevention of vascular disease and low risk for thromboembolism.
Who cannot join
- The patients who taking anti-thrombotic agents,
- The patients who taking thienopyridines or other NSAID with aspirin,
- The patients who have low platelet count(<80,000/mm3) and prolongated PT/aPTT in laboratory test,
- The patients who have chronic renal disease (creatinine>3mg/dl over 6 months),
- The patients who have polyps over than 1 cm in size or thick pedicle over 1 cm,
- The patients who have GI malignancies,the patients who are over ASA classification class III.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Soonchunhyang univerisity hospital
Seoul, Seoul, 140-743
Hyun Gun Kim, MD., PhD., medgun@schmc.ac.kr
Hyun Gun Kim, MD., PhD.
About this study
Official title: Postpolypectomy Bleeding in Patients Undergoing Colonoscopy on Antiplatelet Therapy. - Multicenter, Prospective Observational Study -
The purpose of this study is to determine if the use of aspirin prior to colonoscopy increases the risk of post polypectomy bleeding. The primary end point is comparison of bleeding rates after polypectomy of a continuous aspirin group and temporally aspirin-quit group. The secondary end point is analysis of risk factors which affect early or delayed post polypectomy bleeding.
Read the detailed description
Based on very limited evidences, ASGE recommended that endoscopic procedures may be performed on patients taking aspirin. However in a survey of ASGE members regarding their endoscopic practice, 81% would consider discontinuation of aspirin before colonoscopy and 66% would not perform snare polypectomy if patients had not discontinued aspirin. Although a large prospective randomized control trial would be the ideal way to address this issue theoretically, the investigators hypothesized that there are no differences of the post polypectomy bleeding rate in patients whether continuous taking aspirin prior to polypectomy or not.
In this study, we classified the patients into two groups; the patients who can stop taking aspirin before colon polypectomy will be enrolled into group 1, and the patients who take both thienopyridines and aspirin for their underlying disease and should keep take aspirin during colon polypectomy will be enrolled into group 2. The patients of group 1 stop taking aspirin 7 days before polypectomy.
thromboembolism. Exclusions are as follow; patients taking anti-thrombotic agents, patients have low a platelet count (<80,000/mm3) and/or prolongated PT/aPTT, patients who have chronic renal disease (creatinine>3mg/dl over 6 months), patients who have GI malignancies, patients who are over ASA classification class III, over 2 score of HAS-BLED and over 1 of CHAD2 score. The expected enrolled patients number is 500 patients (250 in each group).
All cases of polypectomy are performed with identical methodology; resection after epinephrine mixture injection under blended or mixed current wave. The data includes the patients information such as sex, age, body weight, BMI and vascular disease history such as hypertension, diabetes, ischemic heart disease, cerebrovascular disease, COPD, modified HAS-BLED score and CHADS2 score. The data of polyp related factor include number of polyps, bleeding status(acute, early, delayed/minimal, moderate, sever), endoscopist (staff or fellow), bowel preparation status, polyp character (shape, location, pathology) and procedures for bleeding (clipping, APC, epinephrine injection, band ligation etc.).
All procedure will be performed with the endoscopist blinded to the patient status of whether the patient is taking aspirin continuously or not.
- Being tested
- Aspirin
- Keywords
- Aspirin, Colon polypectomy, Bleeding
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Aspirin hold for a certain period of time in the patients who take aspirin for the primary prevention of vascular disease,
| Study group | Role | What they receive |
|---|---|---|
| Aspirin holding group | No intervention | Aspirin holding group (group 1): the patients enrolled into group 1 can stop taking aspirin during colon polypectomy. The patients are usually taking aspirin for primary prevention of vascular disease and have no risk of thromboembolism despite of they stop taking aspirin temporary |
| Aspirin continuing group | Experimental | Aspirin continuing group (group 2): the patients enrolled into group 2 should take aspirin during colon polypectomy because these patients are usually take thienopyridines and aspirin, and if they would stop taking aspirin during colon polypectomy, they have a thromboembolism risk. Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
postpolypectomy bleeding rate
Measured: bleeding after polypectomy within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2011 (estimated)
- Study startApr 2012
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bleeding Complication During Colon PolypectomyStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soonchunhyang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun Gun, Kim. M.D., Ph.D., Soonchunhyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01465256
- Sponsor's protocol ID
- KASIDPOLYP
- Status last verified
- Mar 2014
- First submitted
- 1 Nov 2011
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpolypectomy Bleeding in Patients Undergoing Colonoscopy on Antiplatelet Therapy. - Multicenter, Prospective Observational Study -
- ClinicalTrials.gov ID
- NCT01465256
- Acronym / sponsor ID
- KASIDPOLYP
- Keywords
- Aspirin, Colon polypectomy, Bleeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 4 Nov 2011 (estimated)
- 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.
The purpose of this study is to determine if the use of aspirin prior to colonoscopy increases the risk of post polypectomy bleeding. The primary end point is comparison of bleeding rates after polypectomy of a continuous aspirin group and temporally aspirin-quit group. The secondary end point is analysis of risk factors which affect early or delayed post polypectomy bleeding.
Detailed description
Based on very limited evidences, ASGE recommended that endoscopic procedures may be performed on patients taking aspirin. However in a survey of ASGE members regarding their endoscopic practice, 81% would consider discontinuation of aspirin before colonoscopy and 66% would not perform snare polypectomy if patients had not discontinued aspirin. Although a large prospective randomized control trial would be the ideal way to address this issue theoretically, the investigators hypothesized that there are no differences of the post polypectomy bleeding rate in patients whether continuous taking aspirin prior to polypectomy or not.
In this study, we classified the patients into two groups; the patients who can stop taking aspirin before colon polypectomy will be enrolled into group 1, and the patients who take both thienopyridines and aspirin for their underlying disease and should keep take aspirin during colon polypectomy will be enrolled into group 2. The patients of group 1 stop taking aspirin 7 days before polypectomy.
thromboembolism. Exclusions are as follow; patients taking anti-thrombotic agents, patients have low a platelet count (<80,000/mm3) and/or prolongated PT/aPTT, patients who have chronic renal disease (creatinine>3mg/dl over 6 months), patients who have GI malignancies, patients who are over ASA classification class III, over 2 score of HAS-BLED and over 1 of CHAD2 score. The expected enrolled patients number is 500 patients (250 in each group).
All cases of polypectomy are performed with identical methodology; resection after epinephrine mixture injection under blended or mixed current wave. The data includes the patients information such as sex, age, body weight, BMI and vascular disease history such as hypertension, diabetes, ischemic heart disease, cerebrovascular disease, COPD, modified HAS-BLED score and CHADS2 score. The data of polyp related factor include number of polyps, bleeding status(acute, early, delayed/minimal, moderate, sever), endoscopist (staff or fellow), bowel preparation status, polyp character (shape, location, pathology) and procedures for bleeding (clipping, APC, epinephrine injection, band ligation etc.).
All procedure will be performed with the endoscopist blinded to the patient status of whether the patient is taking aspirin continuously or not.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin holding group | No intervention | –Aspirin holding group (group 1): the patients enrolled into group 1 can stop taking aspirin during colon polypectomy. The patients are usually taking aspirin for primary prevention of vascular disease and have no risk of thromboembolism despite of they stop taking aspirin temporary |
| Aspirin continuing group | Experimental | Drug: AspirinAspirin continuing group (group 2): the patients enrolled into group 2 should take aspirin during colon polypectomy because these patients are usually take thienopyridines and aspirin, and if they would stop taking aspirin during colon polypectomy, they have a thromboembolism risk. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The patients who take low dose aspirin (75~160mg) for primary prevention of vascular disease and low risk for thromboembolism.
Key exclusion criteria (6 listed)
- The patients who taking anti-thrombotic agents,
- The patients who taking thienopyridines or other NSAID with aspirin,
- The patients who have low platelet count(<80,000/mm3) and prolongated PT/aPTT in laboratory test,
- The patients who have chronic renal disease (creatinine>3mg/dl over 6 months),
- The patients who have polyps over than 1 cm in size or thick pedicle over 1 cm,
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 |
|---|---|---|
| AspirinAspirin hold for a certain period of time in the patients who take aspirin for the primary prevention of vascular disease, | Drug | Aspirin continuing group |
Primary outcome
postpolypectomy bleeding rate
Time frame: bleeding after polypectomy within 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspirin in people with Bleeding Complication During Colon Polypectomy, run by Soonchunhyang University 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 1 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: status not confirmed, as of the sponsor's last update on 26 Mar 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postpolypectomy bleeding rate (time frame: bleeding after polypectomy within 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2014.