PolypsPhase 4MEDOCNCT01807169
Recto Colonic Endoscopic Mucosal Resection and Polypectomy Under Clopidogrel
A Phase 4 study testing Colonic polypectomy or endoscopic mucosal resection (EMR). in people with Polyps, run by Centre Hospitalier Universitaire de Nice at 3 sites in France.
Trial summary
The endoscopic management of patients on anti platelet agents (APA) is a wide problem, with prevalence of patients on this type of therapy steadily increasing. The benefit / risk balance to stop or continue the APA for the digestive endoscopic procedure confronts us every day in clinical practice to another: the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polyps
- What is being tested?
- Colonic polypectomy or endoscopic mucosal resection (EMR).
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 3 sitesFrance
- Study dates
- 14 May 2013to 7 Nov 2017
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years, male or female
- Polypectomy AND / OR mucosectomy (EMR) performed on clopidogrel and/or aspirin during a colonoscopy with inability to defer action
- Taking a single daily dose of clopidogrel long-term (more than 3 months) or under treatment with clopidogrel and aspirin (aspirin < 375 mg more than 3 months) in the prevention of cardiovascular and thromboembolic risk with a major or medium - secondary prevention
- Affiliation to the regime of national health protection
- Informed consent and patient's written obtained
- No participation in another clinical study
Who cannot join
- Contraindications to the achievement of a lower gastrointestinal endoscopy
- Taking a single daily dose of clopidogrel or other anti-platelet, anti vitamin K (AVK), heparin or anti bi aggregation in the context of cardiovascular prevention
- Taking chronic anti inflammatory drug (at least once weekly)
- Resection technique submucosal dissection
- Haemorrhagic disease, disorders of hemostasis and coagulation (PT <60%, aPTT> 40 sec. And platelets <100000/mm3), hematologic malignancy, chronic liver cirrhosis classified as Child Pugh B or C, acute or chronic renal failure
- Acute Coronary Syndrome <3 months or not received percutaneous coronary intervention (PCI).
Show all 10Show fewer
- Angioplasty with placement of a stent drug evaluation (out of context of acute coronary syndrome) <3 months.
- Angioplasty with placement of a bare metal stent (out of context of acute coronary syndrome) <4 weeks.
- Pregnant women, nursing
- Not signing the written consent and / or mental disabilities of the subject making its participation in the trial impossible
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, 33400
Centre Hospitalier Universitaire de Brest
Brest, 29609
Centre Hospitalier Universitaire de Nice
Nice, 06003
About this study
Official title: Recto Colonic Endoscopic Mucosal Resection and Polypectomy Under Clopidogrel: the "MEDOC"Study.
The endoscopic management of patients on anti platelet agents (APA) is a wide problem, with prevalence of patients on this type of therapy steadily increasing. The benefit / risk balance to stop or continue the APA for the digestive endoscopic procedure confronts us every day in clinical practice to another: the relationship thrombosis / hemorrhage.
Molecules most commonly used today are aspirin and clopidogrel. Current recommendations from the European Society of Gastrointestinal Endoscopy (ESGE) allow the maintenance of aspirin for the polypectomy. Some preliminary data show that the risk of bleeding during endoscopic mucosal resection (EMR) with aspirin is not significantly higher than polypectomy. The concept of polypectomy / EMR without stopping aspirin is progressively accepted and returned gradually to the usual practice. However, these procedures are still not allowed under clopidogrel, or in a dual APA therapy, in the absence of relevant data on the subject in the literature.
Read more
It is necessary to achieve a large national multicenter study, to clarify the risk of post recto colonic EMR and polypectomy bleeding in patients under clopidogrel alone or in combination (aspirin and clopidogrel) taking into account the endoscopic preventive measures used in daily practice by endoscopists in expert centers (clip, ligature and loop devices, preventive adrenalin injection).
The aim of the "MEDOC" study is to determine the incidence of immediate and delayed bleeding after colonic polypectomy and / or EMR for patients on clopidogrel.
It is expected in this work an incidence of post-polypectomy bleeding close to that observed during the implementation of these actions in the population without any anti platelet agents.
Read the detailed description
The endoscopic management of patients on anti platelet agents (APA) is a wide problem, due to the dramatically increasing prevalence of patients on these therapies. The benefit / risk balance to stop or continue the APA for the digestive endoscopic procedure confronts us every day in clinical practice to another: the relationship thrombosis / hemorrhage. The maintenance of an APA is particularly essential for acute coronary episode, but in the long term, in prevention of recurrent thrombotic cardiovascular disease. Molecules most commonly used today are aspirin and clopidogrel.
Current recommendations from the European Society of Gastrointestinal Endoscopy (ESGE) allow the maintenance of aspirin for the polypectomy. Some preliminary data show that the risk of bleeding during endoscopic mucosal resection (EMR) with aspirin is not significantly higher than polypectomy. The concept of polypectomy / EMR without stopping aspirin is progressively accepted and returned gradually to the usual practice. However, these procedures are still not allowed under clopidogrel, or in a dual APA therapy, in the absence of relevant data on the subject in the literature.
However recent studies disrupt this problem for different reasons: i) endoscopic haemostatic preventive measures have demonstrated efficacy in reducing the rate of immediate and delayed bleeding post polypectomy or EMR; ii) the inadequate modification or untimely stopping APA treatment is always complicated by severe vascular thrombosis events in 5% of patients; iii) three retrospective studies relativize the risk of bleeding after a colonic polypectomy under clopidogrel. It is therefore essential to carry out a prospective, large-scale, multicenter, study to clarify the risk of post colonic EMR/polypectomy bleeding in patients under clopidogrel alone or in combination (aspirin and clopidogrel) taking into account the endoscopic preventive measures used in daily practice by endoscopists in expert centers (clip, ligature and loop devices, preventive adrenalin injection).
The aim of the "MEDOC" study is to determine the incidence of immediate and delayed bleeding after colonic polypectomy and / or EMR for patients on clopidogrel.
The study presents an interventional prospective multicentric and national design.
300 patients will be included. The duration of the study inclusions will be 18 months.
It is expected in this work an incidence of post-polypectomy bleeding close to that observed during the implementation of these actions in the population without any anti platelet agents.
- Conditions
- Polyps
- Being tested
- Colonic polypectomy or endoscopic mucosal resection (EMR).
- Keywords
- colon, endoscopy, resection, clopidogrel
- Medical subject headings
- Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonic polypectomy or endoscopic mucosal resection (EMR).Procedure or surgery
Resection of colonic polyps using polypectomy tehnique (with electrocoagulation) or mucosal resection (EMR or mucosectomy) with injection of physiological serum thus resection with electrocoagulation
| Study group | Role | What they receive |
|---|---|---|
| Colonic polypectomy or endoscopic mucosal resection | Experimental | Resection of colonic polyps using polypectomy tehnique (with electrocoagulation) or mucosal resection (EMR or mucosectomy) with injection of physiological serum thus resection with electrocoagulation Receives: Procedure: Colonic polypectomy or endoscopic mucosal resection (EMR). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delayed bleeding after polypectomy and / or colonic mucosectomy
Incidence of delayed bleeding after polypectomy and / or colonic mucosectomy (endoscopic mucosal resection) in patients on clopidogrel
Measured: during surgery, hospitalization and at 30 days
Secondary outcomes (5)
Incidence of immediate bleeding after polypectomy and / or colonic mucosectomy
Measured: during surgery, hospitalization and at 30 days
Incidence of severe bleeding after polypectomy and / or colonic mucosectomy in patients on Clopidogrel
Measured: during surgery, hospitalization and at 30 days
Efficacy of endoscopic hemostasis in case of bleeding induced
Defined by the cessation of bleeding without the need for further treatment (surgery, radiation)
Measured: in case of bleeding induced
morbidity / mortality induced by immediate and delayed bleeding after polypectomy and / or colonic mucosectomy in patients on clopidogrel
Measured: during surgery, hospitalization and at 30 days
predictors of gastrointestinal bleeding post polypectomy / mucosectomy under clopidogrel by sub groups of patients obtained
Measured: during surgery, hospitalization and at 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study start14 May 2013
- Primary completion7 Nov 2017
- Study completion7 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolypsStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geoffroy VANBIERVLIET, MD, Study director, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807169
- Sponsor's protocol ID
- 12-AOI-05
- Other IDs
- 2012-005365-12
- Acronym
- MEDOC
- Status last verified
- Aug 2018
- First submitted
- 4 Mar 2013
- Last updated
- 6 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recto Colonic Endoscopic Mucosal Resection and Polypectomy Under Clopidogrel: the "MEDOC"Study.
- ClinicalTrials.gov ID
- NCT01807169
- Acronym / sponsor ID
- MEDOC / 12-AOI-05
- Conditions
- Polyps
- Keywords
- colon, endoscopy, resection, clopidogrel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 14 May 2013 (actual)
- Primary completion
- 7 Nov 2017 (actual)
- Study completion
- 7 Nov 2017 (actual)
- First posted
- 8 Mar 2013 (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 endoscopic management of patients on anti platelet agents (APA) is a wide problem, with prevalence of patients on this type of therapy steadily increasing. The benefit / risk balance to stop or continue the APA for the digestive endoscopic procedure confronts us every day in clinical practice to another: the relationship thrombosis / hemorrhage.
Molecules most commonly used today are aspirin and clopidogrel. Current recommendations from the European Society of Gastrointestinal Endoscopy (ESGE) allow the maintenance of aspirin for the polypectomy. Some preliminary data show that the risk of bleeding during endoscopic mucosal resection (EMR) with aspirin is not significantly higher than polypectomy. The concept of polypectomy / EMR without stopping aspirin is progressively accepted and returned gradually to the usual practice. However, these procedures are still not allowed under clopidogrel, or in a dual APA therapy, in the absence of relevant data on the subject in the literature.
It is necessary to achieve a large national multicenter study, to clarify the risk of post recto colonic EMR and polypectomy bleeding in patients under clopidogrel alone or in combination (aspirin and clopidogrel) taking into account the endoscopic preventive measures used in daily practice by endoscopists in expert centers (clip, ligature and loop devices, preventive adrenalin injection).
The aim of the "MEDOC" study is to determine the incidence of immediate and delayed bleeding after colonic polypectomy and / or EMR for patients on clopidogrel.
It is expected in this work an incidence of post-polypectomy bleeding close to that observed during the implementation of these actions in the population without any anti platelet agents.
Detailed description
The endoscopic management of patients on anti platelet agents (APA) is a wide problem, due to the dramatically increasing prevalence of patients on these therapies. The benefit / risk balance to stop or continue the APA for the digestive endoscopic procedure confronts us every day in clinical practice to another: the relationship thrombosis / hemorrhage. The maintenance of an APA is particularly essential for acute coronary episode, but in the long term, in prevention of recurrent thrombotic cardiovascular disease. Molecules most commonly used today are aspirin and clopidogrel.
Current recommendations from the European Society of Gastrointestinal Endoscopy (ESGE) allow the maintenance of aspirin for the polypectomy. Some preliminary data show that the risk of bleeding during endoscopic mucosal resection (EMR) with aspirin is not significantly higher than polypectomy. The concept of polypectomy / EMR without stopping aspirin is progressively accepted and returned gradually to the usual practice. However, these procedures are still not allowed under clopidogrel, or in a dual APA therapy, in the absence of relevant data on the subject in the literature.
However recent studies disrupt this problem for different reasons: i) endoscopic haemostatic preventive measures have demonstrated efficacy in reducing the rate of immediate and delayed bleeding post polypectomy or EMR; ii) the inadequate modification or untimely stopping APA treatment is always complicated by severe vascular thrombosis events in 5% of patients; iii) three retrospective studies relativize the risk of bleeding after a colonic polypectomy under clopidogrel. It is therefore essential to carry out a prospective, large-scale, multicenter, study to clarify the risk of post colonic EMR/polypectomy bleeding in patients under clopidogrel alone or in combination (aspirin and clopidogrel) taking into account the endoscopic preventive measures used in daily practice by endoscopists in expert centers (clip, ligature and loop devices, preventive adrenalin injection).
The aim of the "MEDOC" study is to determine the incidence of immediate and delayed bleeding after colonic polypectomy and / or EMR for patients on clopidogrel.
The study presents an interventional prospective multicentric and national design.
300 patients will be included. The duration of the study inclusions will be 18 months.
It is expected in this work an incidence of post-polypectomy bleeding close to that observed during the implementation of these actions in the population without any anti platelet agents.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colonic polypectomy or endoscopic mucosal resection | Experimental | Procedure: Colonic polypectomy or endoscopic mucosal resection (EMR).Resection of colonic polyps using polypectomy tehnique (with electrocoagulation) or mucosal resection (EMR or mucosectomy) with injection of physiological serum thus resection with electrocoagulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years, male or female
- Polypectomy AND / OR mucosectomy (EMR) performed on clopidogrel and/or aspirin during a colonoscopy with inability to defer action
- Taking a single daily dose of clopidogrel long-term (more than 3 months) or under treatment with clopidogrel and aspirin (aspirin < 375 mg more than 3 months) in the prevention of cardiovascular and thromboembolic risk with a major or medium - secondary prevention
- Affiliation to the regime of national health protection
- Informed consent and patient's written obtained
Key exclusion criteria (10 listed)
- Contraindications to the achievement of a lower gastrointestinal endoscopy
- Taking a single daily dose of clopidogrel or other anti-platelet, anti vitamin K (AVK), heparin or anti bi aggregation in the context of cardiovascular prevention
- Taking chronic anti inflammatory drug (at least once weekly)
- Resection technique submucosal dissection
- Haemorrhagic disease, disorders of hemostasis and coagulation (PT <60%, aPTT> 40 sec. And platelets <100000/mm3), hematologic malignancy, chronic liver cirrhosis classified as Child Pugh B or C, acute or chronic renal failure
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 |
|---|---|---|
| Colonic polypectomy or endoscopic mucosal resection (EMR).Resection of colonic polyps using polypectomy tehnique (with electrocoagulation) or mucosal resection (EMR or mucosectomy) with injection of physiological serum thus resection with electrocoagulation | Procedure or surgery | Colonic polypectomy or endoscopic mucosal resection |
Primary outcome
Incidence of delayed bleeding after polypectomy and / or colonic mucosectomy
Time frame: during surgery, hospitalization and at 30 days
Incidence of delayed bleeding after polypectomy and / or colonic mucosectomy (endoscopic mucosal resection) in patients on clopidogrel
5 secondary outcomes
Incidence of immediate bleeding after polypectomy and / or colonic mucosectomy
Time frame: during surgery, hospitalization and at 30 days
Incidence of severe bleeding after polypectomy and / or colonic mucosectomy in patients on Clopidogrel
Time frame: during surgery, hospitalization and at 30 days
Efficacy of endoscopic hemostasis in case of bleeding induced
Time frame: in case of bleeding induced
morbidity / mortality induced by immediate and delayed bleeding after polypectomy and / or colonic mucosectomy in patients on clopidogrel
Time frame: during surgery, hospitalization and at 30 days
predictors of gastrointestinal bleeding post polypectomy / mucosectomy under clopidogrel by sub groups of patients obtained
Time frame: during surgery, hospitalization and at 30 days
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 6 Aug 2018.
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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.
Geoffroy VANBIERVLIET, MD study director
Centre Hospitalier Universitaire de Nice
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Colonic polypectomy or endoscopic mucosal resection (EMR). in people with Polyps, run by Centre Hospitalier Universitaire de Nice at 3 sites in France.
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 6 inclusion and 10 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 6 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of delayed bleeding after polypectomy and / or colonic mucosectomy (time frame: during surgery, hospitalization and at 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 6 Aug 2018.