Colon PolypNCT02120170
Prophylactic Clip Application for Colon Polypectomy in Patients With Anticoagulation
A study testing Colon polypectomy in people with Colon Polyp, run by Soonchunhyang University Hospital at 1 site in South Korea.
Trial summary
There have been very limited evidence about the bleeding complication during colon polypectomy for the patients taking warfarin. This study is aimed to analyse the effect of prophylactic hemo-clipping during colon polypectomy for the patients with warfarin consumption. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Colon Polyp
- What is being tested?
- Colon polypectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2014to Apr 2017
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects who should take heparin bridging therapy after quit warfarin 3~5 days before colon polypectomy because of high risk of thromboembolism - AF with valvular disease, AF with mechanical valve, AF with CHF, EF <35%, AF with previous thromboembolism, AF with DM and HTN, AF with old age(>75),
Who cannot join
- patients who don't have to take bridging heparin therapy after quit warfarin, patients have low a platelet count (<80,000/mm3), patients who take anti-platelet agents, patients who have GI malignancies.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Soonchunhyang University Hospital
Seoul, Seoul, 140-743
Hyun Gun Kim, MD.,PhD., 8227099852, medgun@schmc.ac.kr
Hyun Gun Kim, MD.,PhD.
About this study
Official title: The Effect of Prophylactic Clip Application for Colon Polypectomy in Patients With Anticoagulation: Prospective Randomized Controlled Trial
There have been very limited evidence about the bleeding complication during colon polypectomy for the patients taking warfarin.
This study is aimed to analyse the effect of prophylactic hemo-clipping during colon polypectomy for the patients with warfarin consumption.
Read more
The enrolled subjects are the patients who take warfarin for high thromboembolism risk and should take heparin bridging therapy during colon polypectomy instead of temporary stopping warfarin. The investigators will randomize into two groups; the patient enrolled into group 1 will be performed hemoclipping for all polypectomy lesion irrespective of the presence of immediate bleeding. And the patients enrolled into group 2 will be performed hemoclipping only for the lesion of immediate bleeding during colon polypectomy.
The primary endpoint is to compare the rate of delayed bleeding between two groups.
Read the detailed description
The American guideline have recommended that if the patient with low risk of thromboembolism, warfarin consumption can be quit 3~5 days before colon polypectomy and resume within 24 hours after polypectomy. However, if the patient were high risk of thromboembolism, the patient should take heparin bridging therapy during temporal quit of warfarin consumption for colon polypectomy. There have been very limited evidences about the bleeding complication during colon polypectomy for the patients with warfarin taking.
Moreover, there have been lack of evidence that how to prevent the bleeding complication in the patients with high risk of thromboembolism who should take heparin bridging therapy during temporal stopping of warfarin for colon polypectomy.
This study is aimed to analyse the effect of prophylactic hemo-clipping during colon polypectomy for the patients with warfarin consumption.
The investigators will enroll the subjects who should take heparin bridging therapy (quit warfarin 3~5 days before colon polypectomy and check the INR, if the INR <2, heparin or low molecular heparin should be start. If the INR <1.5 on the day before colon polypectomy, the patient will undergo bowel preparation and colon polypectomy. Warfarin will resume within 24 hour after polypectomy) after quit warfarin for during colon polypectomy over 19 years old.
Exclusions are as follow; patients who don't have to take bridging heparin therapy after quit warfarin, patients have low a platelet count (<80,000/mm3), patients who take anti-platelet agents, patients who have GI malignancies. The investigators will randomize into two groups; the patient enrolled into group 1 will be performed hemoclipping for all polypectomy lesion irrespective of the presence of immediate bleeding. And the patients enrolled into group 2 will be performed hemoclipping only for the lesion of immediate bleeding during colon polypectomy. Including polyps for colon polypectomy are 6~ 20 mm size and polypectomy procedure is defined as EMR after injection with blended electrical current.
The lesion which immediate bleeding is occurred during the polypectomy will be performed hemoclipping irrespective of group and will not be counted as delayed bleeding even though delayed bleeding is occurred on this lesion.
The primary endpoint is to compare the rate of delayed bleeding between two groups. The secondary endpoint is to analyse the effect of hemoclipping for immediate bleeding.
This study will be performed during 3 years after 1st patient enrollment and the target size of enrollment is 356 (176 in each group).
- Conditions
- Colon Polyp
- Being tested
- Colon polypectomy
- Keywords
- Hemoclip, Heparin bridging therapy, colon polypectomy, warfarin
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colon polypectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Hemoclipping during colon polypectomy for all lesion | Active comparator | The enrolled patients of group 1 will be performed hemoclipping for all polypectomy lesion irrespective of the presence of immediate bleeding. Receives: Procedure: Colon polypectomy |
| No hemoclipping if there were no bleeding during polypectomy | No intervention | The patients of group 2 will be performed hemoclipping only for the immediate bleeding during colon polypectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with delayed bleeding
The primary endpoint is to compare the rate of delayed bleeding between two groups.
Measured: Bleeding within 30 days after colon polypectomy
Secondary outcomes (1)
Number of successful bleeding control after hemoclipping for immediate bleeding in the patients with warfarin.
The secondary endpoint is to analyse the effect of hemoclipping for immediate bleeding and will be measured as successful hemostasis rate of hemoclipping. There has limited evidence about the efficacy of hemoclipping for the immediate bleeding during colon polypectomy in the patients with anticoagulation
Measured: Bleeding during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionMar 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon PolypStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 356 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
- Investigators
- Hyun Gun Kim, MD.,PhD., Principal investigator, Soonchunhyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120170
- Sponsor's protocol ID
- CLIPO
- Status last verified
- Apr 2014
- First submitted
- 27 Mar 2014
- Last updated
- 23 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prophylactic Clip Application for Colon Polypectomy in Patients With Anticoagulation: Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02120170
- Acronym / sponsor ID
- CLIPO
- Conditions
- Colon Polyp
- Keywords
- Hemoclip, Heparin bridging therapy, colon polypectomy, warfarin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 356 participants (estimated)
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 22 Apr 2014 (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.
There have been very limited evidence about the bleeding complication during colon polypectomy for the patients taking warfarin.
This study is aimed to analyse the effect of prophylactic hemo-clipping during colon polypectomy for the patients with warfarin consumption.
The enrolled subjects are the patients who take warfarin for high thromboembolism risk and should take heparin bridging therapy during colon polypectomy instead of temporary stopping warfarin. The investigators will randomize into two groups; the patient enrolled into group 1 will be performed hemoclipping for all polypectomy lesion irrespective of the presence of immediate bleeding. And the patients enrolled into group 2 will be performed hemoclipping only for the lesion of immediate bleeding during colon polypectomy.
The primary endpoint is to compare the rate of delayed bleeding between two groups.
Detailed description
The American guideline have recommended that if the patient with low risk of thromboembolism, warfarin consumption can be quit 3~5 days before colon polypectomy and resume within 24 hours after polypectomy. However, if the patient were high risk of thromboembolism, the patient should take heparin bridging therapy during temporal quit of warfarin consumption for colon polypectomy. There have been very limited evidences about the bleeding complication during colon polypectomy for the patients with warfarin taking.
Moreover, there have been lack of evidence that how to prevent the bleeding complication in the patients with high risk of thromboembolism who should take heparin bridging therapy during temporal stopping of warfarin for colon polypectomy.
This study is aimed to analyse the effect of prophylactic hemo-clipping during colon polypectomy for the patients with warfarin consumption.
The investigators will enroll the subjects who should take heparin bridging therapy (quit warfarin 3~5 days before colon polypectomy and check the INR, if the INR <2, heparin or low molecular heparin should be start. If the INR <1.5 on the day before colon polypectomy, the patient will undergo bowel preparation and colon polypectomy. Warfarin will resume within 24 hour after polypectomy) after quit warfarin for during colon polypectomy over 19 years old.
Exclusions are as follow; patients who don't have to take bridging heparin therapy after quit warfarin, patients have low a platelet count (<80,000/mm3), patients who take anti-platelet agents, patients who have GI malignancies. The investigators will randomize into two groups; the patient enrolled into group 1 will be performed hemoclipping for all polypectomy lesion irrespective of the presence of immediate bleeding. And the patients enrolled into group 2 will be performed hemoclipping only for the lesion of immediate bleeding during colon polypectomy. Including polyps for colon polypectomy are 6~ 20 mm size and polypectomy procedure is defined as EMR after injection with blended electrical current.
The lesion which immediate bleeding is occurred during the polypectomy will be performed hemoclipping irrespective of group and will not be counted as delayed bleeding even though delayed bleeding is occurred on this lesion.
The primary endpoint is to compare the rate of delayed bleeding between two groups. The secondary endpoint is to analyse the effect of hemoclipping for immediate bleeding.
This study will be performed during 3 years after 1st patient enrollment and the target size of enrollment is 356 (176 in each group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemoclipping during colon polypectomy for all lesion | Active comparator | Procedure: Colon polypectomyThe enrolled patients of group 1 will be performed hemoclipping for all polypectomy lesion irrespective of the presence of immediate bleeding. |
| No hemoclipping if there were no bleeding during polypectomy | No intervention | –The patients of group 2 will be performed hemoclipping only for the immediate bleeding during colon polypectomy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- subjects who should take heparin bridging therapy after quit warfarin 3~5 days before colon polypectomy because of high risk of thromboembolism - AF with valvular disease, AF with mechanical valve, AF with CHF, EF <35%, AF with previous thromboembolism, AF with DM and HTN, AF with old age(>75),
Key exclusion criteria (1 listed)
- patients who don't have to take bridging heparin therapy after quit warfarin, patients have low a platelet count (<80,000/mm3), patients who take anti-platelet agents, patients who have GI malignancies.
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 |
|---|---|---|
| Colon polypectomy | Procedure or surgery | Hemoclipping during colon polypectomy for all lesion |
Primary outcome
Number of participants with delayed bleeding
Time frame: Bleeding within 30 days after colon polypectomy
The primary endpoint is to compare the rate of delayed bleeding between two groups.
1 secondary outcome
Number of successful bleeding control after hemoclipping for immediate bleeding in the patients with warfarin.
Time frame: Bleeding during the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2014.
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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.,PhD. principal investigator
Soonchunhyang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colon polypectomy in people with Colon Polyp, 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 1 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 23 Apr 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?
Contact HYUN GUN KIM, MD.,PhD. (8227099852, medgun@schmc.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with delayed bleeding (time frame: Bleeding within 30 days after colon polypectomy). 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 23 Apr 2014.