Polyps Clinical Trial
— MEDOCOfficial title:
Recto Colonic Endoscopic Mucosal Resection and Polypectomy Under Clopidogrel: the "MEDOC"Study.
Verified date | August 2018 |
Source | Centre Hospitalier Universitaire de Nice |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 39 |
Est. completion date | November 7, 2017 |
Est. primary completion date | November 7, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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). - 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 |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier Universitaire de Bordeaux | Bordeaux | |
France | Centre Hospitalier Universitaire de Brest | Brest | |
France | Centre Hospitalier Universitaire de Nice | Nice |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nice |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | during surgery, hospitalization and at 30 days | |
Secondary | Incidence of immediate bleeding after polypectomy and / or colonic mucosectomy | during surgery, hospitalization and at 30 days | ||
Secondary | Incidence of severe bleeding after polypectomy and / or colonic mucosectomy in patients on Clopidogrel | during surgery, hospitalization and at 30 days | ||
Secondary | Efficacy of endoscopic hemostasis in case of bleeding induced | Defined by the cessation of bleeding without the need for further treatment (surgery, radiation) | in case of bleeding induced | |
Secondary | morbidity / mortality induced by immediate and delayed bleeding after polypectomy and / or colonic mucosectomy in patients on clopidogrel | during surgery, hospitalization and at 30 days | ||
Secondary | predictors of gastrointestinal bleeding post polypectomy / mucosectomy under clopidogrel by sub groups of patients obtained | during surgery, hospitalization and at 30 days |
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